iStock(NEW YORK ) -- Despite repeated warnings from health experts about the risk of social interaction over novel coronavirus, governors in at least three states have exempted houses of worship from statewide bans on mass gatherings, and this weekend will offer a first test to see if any congregations forge ahead despite the warnings.
Michigan Gov. Gretchen Whitmer, a Democrat, has banned gatherings of 50 or more and signed a statewide stay-at-home order on Monday. But both mandates explicitly exempt houses of worship from the misdemeanor penalty for violators.
"That’s an area we don’t have the ability to directly enforce or control," Whitmer said during an appearance on "Fox News Sunday."
She said she felt pressure from Republicans in the state legislature to include the exemption and said her hands were tied by the separation of church and state.
Democratic Kansas Gov. Laura Kelly tightened restrictions on mass gatherings in her state to no more than 10 people. But much like with Michigan, she exempted houses of worship as long as congregants engage in appropriate social distancing. Ohio officials carved out exemptions for religious gatherings, including weddings and funerals, from its stay-at-home order, on top of a broad exemption for any gathering "for the purpose of the expression of First Amendment protected speech."
Not everyone believes that imposing constraints on religious gatherings would run afoul of constitutional protections.
Rachel Laser, the president and CEO of the nonprofit advocacy group Americans United for the Separation of Church and State, said the governors are misinterpreting restrictions on impeding religious expression. She says the Constitution actually requires religious and secular institutions be treated the same.
"The Constitution not only permits it, but demands it," she said in a statement. "Such restrictions do not violate religious freedom; they ensure religious freedom is not misused in ways that risk people’s lives."
Laser’s organization has tracked mass gathering bans by state, and cites numerous instances in which COVID-19 has spread through congregations, sometimes resulting in deaths.
"We recognize that many people find solace in attending religious services, especially during uncertain times such as these, and thus share in the deep sorrow that the already challenging coronavirus situation also means temporarily halting in-person religious services," Laser said.
This handout illustration image taken with a scanning electron microscope shows SARS-CoV-2 (yellow) also known as 2019-nCoV, the virus that causes COVID-19isolated emerging from the surface of cells (blue/pink) cultured in the lab.
She applauded the houses of worship that are taking creative approaches to maintaining their fellowship in this time of social distancing, including streaming services online.
"We may be physically apart, but we will get through this public health crisis together -- even if it’s together in new ways," Laser said.
In Michigan, Whitmer has been urging houses of worship not to host services, despite the exemption. But last weekend some churches in the state were still holding services. Greater Grace Temple in Detroit welcomed about 200 worshipers last Sunday – four times more than the state’s mass gatherings ban allows, but far fewer than the 4,000-seat sanctuary can hold.
"Unless you were a couple or a parent and children, everyone was sitting about four to five seats separated from each other," Bishop Charles H. Ellis III of Greater Grace Temple told ABC News in a phone interview.
On Tuesday, following the governor’s stay-at-home order, Greater Grace Temple suspended worship services for at least three weeks.
"We want to certainly cooperate and do our best to adhere to what she's asking us to do," Ellis said. "We certainly don't want to be above the system."
Even in states with strict bans on mass gatherings of any kind, some faith groups are continuing to worship together.
In New York, which is now the epicenter of the outbreak in the United States, local news reports indicate many ultra-Orthodox Jews in Brooklyn have anguished over the ban, with many refusing to comply. Last week, The New York Times reported that the fire department had to be called to break up hundreds of revelers celebrating at a Hasidic wedding in Brooklyn.
In Louisiana, the pastor at the Life Tabernacle Church outside of Baton Rouge, vowed to continue worship services for a congregation of more than 1,000 members, according to news reports. The Rev. Tony Spell told CNN, "If they close every door in this city, then I will close my doors. But you can't say the retailers are essential but the church is not. That is a persecution of the faith."
About a dozen states still have not banned mass gatherings at all.
One of those states is Arkansas, where a parish in the small town of Greers Ferry is mourning the loss of a 91-year-old door greeter after 34 members of the 80-person congregation became infected with COVID-19 at a church gathering.
President Donald Trump has told the American people he is holding on to the hope that normal life will resume by Easter, so there can be "packed churches all over our country."
Back in Michigan, one church has found a new way to safely worship. All God’s People Church in Roseville is hosting what Rev. W.J. Rideout III calls "drive-in" service in the parking lot where parishioners stay in their cars.
"I’m the only one outside preaching and ministering God’s words to people for safety measures," he said, adding, "Ecclesiastes says, you know, 'There's a time to embrace and there's a time to refrain from the embracing.' So this is that moment."
Copyright © 2020, ABC Audio. All rights reserved.
iStock(NEW YORK) -- As health care providers across the nation continuing testing for the novel coronavirus, many medical supplies are in high demand and short supply. In particular, there's a dire shortage of nasal swabs used for testing.
A team at Northwell Health in New Hyde Park, New York, might have a solution: a publicly available template for 3D-printed nasal swabs.
"With the COVID-19 virus, our best weapon against it right now is widespread testing," said Dr. Todd Goldstein, director of 3D Design and Innovation at Northwell Health. "This swab is the first line of defense, so to speak, against the coronavirus, because we need to test people and know if they're positive or not. And in order to do that, we have to collect samples."
Northwell Health is now 3D printing around 2,000 to 3,000 nasal swabs a day for immediate use on the front lines of this pandemic. Northwell Health teamed up with the University of South Florida in Tampa and Formlabs in Somerville, Massachusetts, and began 3D printing the novel nasal swabs.
By releasing their design to the public, Northwell Health is looking to decentralize production from strained manufacturers.
"Anyone who has these printers and materials -- we're talking dental labs, university hospitals, high schools, middle schools, universities, engineering schools, even companies that use these printers for prototyping ... if they get the correct resin, they can also make these swabs and help with the shortages," said Goldstein.
Nasal swabs can't be made from common materials like cotton or wood, instead, they're typically made from polyester. The 3D-printed nasal swabs are created from plastic, a perfectly acceptable material to use to make nasal swabs that's also ideal for 3D printing.
While the Food and Drug Administration cautioned against the usage of 3D printing for protective medical supplies on March 26, Goldstein clarified that nasal swabs are not considered "protective" equipment, so Northwell is free to continue printing nasal swabs without any regulatory hang-ups.
"It's an interesting situation where we're able to repurpose the materials for this, and there is an abundance of supply" of those materials, said Goldstein. Because many hospitals have stopped elective surgeries, plastic is readily available.
As the health care industry works tirelessly during this pandemic, collaboration is key to support our health care system, said Goldstein.
"We have engineers from all over the spectrum working to help produce these things," he said. "With all of us together, we'll be able to get over this."
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iStock(NEW ORLEANS) -- In Louisiana, amid skyrocketing rates of the novel coronavirus and a statewide stay-at-home order, scientists are finding themselves face-to-face with the virus they hope to develop a vaccine for.
At the Tulane National Primate Research Center (TNPRC), scientists from across the United States are coordinating their research in nonhuman primates, like rhesus macaques, to develop diagnostics, treatments and vaccines for the novel coronavirus, COVID-19.
These scientists are on the front lines of fighting COVID-19. Like health care workers and first responders across the country, they understand how fast they have to work to save as many lives as possible and are facing many of the same challenges.
“I think we’re pretty busy,” said Dr. Rudolph “Skip” Bohm, associate director of the TNPRC about 40 miles outside New Orleans. “The thing is, though, that in order to win this battle against the COVID pandemic, the research we’re doing is essential. So what we know is that if we push and we’re busy, it’s the only way we’re going to find therapies or vaccines that are going to save thousands of lives worldwide.
“All of us are of that mindset that we got to push through this and ramp it up and get this done because that is what we do,” he said.
As of Saturday morning, there were at least 601,478 cases of COVID-19 and 27,862 deaths globally, with 104,837 cases and 1,711 deaths in the United States.
On Thursday, the scientists entered a new phase in their search for a COVID-19 vaccine when they inoculated four monkeys — two rhesus macaques and two African green monkeys — with the virus. Bohm said they decided on four through a statistical model that determined that’s how many they’d need “to answer the questions we needed” while also using the fewest number of animals possible.
Every few days moving forward, they plan on analyzing the animals with X-Rays and taking blood, fluid and, eventually, tissue samples in an effort to see how the virus works inside their bodies. If the results are as they expect, the infection in the monkeys will mimic that in humans, Bohm said.
“Once we show that the disease looks the same — so the same percentage of animals get sick as in the human population, they have the same sort of illness and the same sort of symptoms as humans — then we can use them to test vaccines or develop treatments,” Bohm said.
A vaccine wouldn’t be available for at least a year, Bohm said.
“That’s actually pretty rapid, believe it or not, to be able to do these things in that fashion,” he said, noting the steps they need to take to launch on the study, from designing it to getting federal approval.
Earlier this month, a federally funded phase 1 clinical trial on an experimental COVID-19 vaccine began in Seattle, where four volunteers were given jabs at the Kaiser Permanente Washington Health Research Institute. There will be a total of 45 people enrolled in the trial.
The clinical trial is using a vaccine that had been developed to prevent SARS and MERS, two other pathogens that fall in the coronavirus family. Bohm said the researchers working on the vaccine were able to move quickly into human clinical trials because the vaccine had already been tested in animals and proven safe.
“That’s fortunate that there was a vaccine developed and [it] never went into production because now they could pick it up where they left off,” he said.
A phase 1 clinical human trial for a COVID-19 vaccine also began in China on March 19.
At the TNPRC, researchers are starting essentially from scratch, studying the “coronavirus that is causing the disease right now,” COVID-19, Bohm said.
He said the National Institutes of Health, which funds the center, is just now “opening up the possibility for acquiring grants to study the coronavirus.” A typical study involving up to six monkeys can cost between $300,000 and $600,000 per vaccine and that their animal model study alone will cost an estimated $345,000 in internal funds.
Angie Birnbaum, director of biosafety at Tulane University, is responsible for the safety of not only those working inside the laboratories where these tests on COVID-19 are being done but also those outside of them, working to ensure the pathogens they work with stay inside the labs.
“These laboratories are incredibly specialized so when you look in a space like this, you’re going to see, basically, a tight seal offering maximum containment,” Birnbaum explained.
The labs, she said, are pressure tested to ensure there aren’t any hidden holes through which the virus can escape. Specially designed ventilation systems prevent the virus from spreading throughout the building.
There are different levels of protocols necessary for the researchers to enter different labs, too. In some, they may not be allowed to wear street clothes under their personal protective gear, Birnbaum said. They might have to wear double layers of gloves or a mask that pushes air out so that a virus can’t accidentally reach their mouth, nose or eyes. As they leave, they also have to go through the proper decontamination and sterilization procedures, Bohm said.
The TNPRC has only just begun testing the monkeys with COVID-19. And while Birnbaum says they have enough supplies to handle upcoming studies, like personal protective equipment, pipettes, plates and other research materials, she expressed concern over the supply chain. Everything is backordered, she said.
After meetings with the other national primate centers around the U.S., she said this is an issue they could face, too.
“The same struggles we are having here, we can also see that other institutions are struggling,” Birnbaum said. “Things like personal protective equipment deficits, shortages which can really impact our ability to do this type of protective way in high containment… This is a very unique pandemic situation in the sense that normally you don’t have this type of massive loss of those types of resources.”
“So, we’re really trying to think outside the box and figure out ways to carry this on because we’re all heart and soul into it,” she continued. “But, you know, there are so many things that are flying at us and the other centers are dealing with that, too.”
A spokesperson for the TNPRC said the facility has historically received PPE through private distributors and companies and that it would continue to do so as long as they continue to meet their needs.
Louisiana Gov. John Bel Edwards ordered all residents of the state to stay home on Sunday, March 22, the same day that he said during a press conference that the state had seen faster growth in the number of COVID-19 cases in the first 13 days than any other state or country in the world. By Saturday morning, Louisiana had 2,746 confirmed cases of the infection and 119 deaths.
Bohm said that due to the speed at which they have to work and because they can’t cut corners in their testing, they’re ramping up the hours they’re putting into their work. At the same time, he said the TNPRC had not previously seen an infection spread through his community like COVID-19 has, and that it’s created special challenges.
“The effect of the disease is pretty profound in our ability to do the research because of staffing and people having to work from home,” Bohm said, noting that if people on staff become ill, they may have to readjust schedules or even train other scientists on how to work in certain labs.
Nobody on the facility’s staff was sick as of Friday evening, a spokesperson for the TNPRC said.
Bohm is also concerned for the monkeys. With 4,500 monkeys living on the property, he said there’s a “high suspicion” that rhesus macaques are susceptible to the novel coronavirus based on preliminary data.
“What that means is that our breeding colony is susceptible to infections for humans — from our workers,” Bohm said. “Knowing that sometimes people are sharing the virus or infectious before they get sick is a real concern of ours. … If they are infected and get sick, and they recover, they most likely can’t be used in any coronavirus research.”
Bohm said his facility has been “fielding calls every single day and having lots of meetings with scientists” from around the country who have vaccines, therapies and diagnostic tests that they want to develop.
“So, we’ll be doing as many of those as we can. But with a network of seven primate research centers, we’re all contributing to that effort to get this done. … This is what the primate centers and other research facilities were designed for — when something happens,” Bohm said. “And so, we’re prepared to do that.”
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iStock(NEW YORK) -- As government and health care officials plead for expanded access to high-speed COVID-19 tests, health care companies across the country began mobilizing their resources to meet the growing demands with direct-to-consumer kits.
The benefits of such kits could be substantial, allowing everyday people to test themselves for COVID-19 in the privacy of their homes instead of visiting a hospital, potentially exposing health care workers and other healthy individuals. If the test came back negative, it could allow them to go back to work without fear of infecting others.
But the path to commercialization has been a bumpy one. On March 16, the Food and Drug Administration issued new, loosened guidelines meant to help accelerate the availability of different types of COVID-19 diagnostic tests. Under the new policy, laboratories approved by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) were allowed to manufacture and distribute a validated COVID-19 test for 15 days before submitting official Emergency Use Authorization from the FDA.
Gail Javitt, director of the Hyman Phelps and McNamara Center, told ABC News that the FDA's relaxed rules were not intended to last forever.
"Emergency use authorization is not approval," she said. "Once an emergency is over, distribution has to cease."
Nevertheless, the relaxed regulatory process effectively gave companies and independent laboratories the green light to start scaling up small COVID-19 testing kits to be shipped to individual homes.
Several companies, such as Everlywell and Nurx, had already started distributing their at-home kits when the FDA issued a surprise notice on March 20.
In that note, the FDA said it had "not authorized any test that is available to purchase for testing yourself at home" and urged people to avoid at-home COVID-19 tests. In part, the FDA took action because the agency was trying to protect consumers from "fraudulent" test kits - scammers selling fake kits.
The following day, the FDA further clarified that the at-home COVID-19 testing, "including self-collection of samples to be sent to a clinical laboratory," were not included in the updated EUA policy exemptions issued on March 16.
Companies that had been ramping up at home COVID-19 tests are in regulatory limbo, and many have decided to tap the brakes on production.
Javitt said some of the companies that pulled back production were specifically distributing at-home collection kits. Consumers would collect a specimen at home, but the test itself would be done in a certified laboratory. The FDA took issue with a non-health care provider collecting the specimen.
"What was being distributed was just a collection device, and the FDA said it was not permitted to distribute those collection devices for specimens," said Javitt.
The San Francisco-based health startup Nurx launched its at-home COVID-19 testing kits on Friday but when "the FDA issued new guidance on Saturday specific to self-collection tests like the one we offer, exempting them from the EUA, we and our partner lab decided to make the responsible decision and pause our service for the time being."
Meanwhile, Texas-based Everywell, a company that has been offering more than 35 different kinds of at-home health test kits, built the infrastructure to start direct-to-consumer COVID-19 testing. Following the FDA's announcement, Everywell said it would switch gears and provide its kits to hospitals and health care companies until further notice.
"I do think many of the companies are being cautious because they are worried or cautious with the increased regulatory oversight going on with regards to them," said Dr. Amesh Adalja, Senior Scholar at Johns Hopkins Health Security Center.
Nurx and Everywell, among other health care startups now in limbo waiting for more clarity as to whether or not they can resume manufacturing and distributing their at-home tests.
"Certainly, there are competing considerations. We do not want fraudulent kits out there," said Javitt in regards to FDA's warning against at-home test kits. "At the same time, there are some legitimate reasons and obvious public health value to keeping people out of the public clinics, out of the hospitals and at home, whether they are negative or positive."
The FDA admits that safe and accurate home collection tests would expand availability of COVID-19 testing. The agency said it is working to "help in meeting the increasing demands for tests is "are actively working with test developers in this space." Such language suggests that COVID19 collection kits may in fact reach a person's front door in the near future.
Adalja agrees, admitting that the FDA's regulations are somewhat ambiguous.
"The home collection kits are not truly home test kits." For example, Everywell's at-home kit only provides a special swab that allows a user to collect a specimen from their nose at home. But you don't get the results right then and there. Instead, the specimen is sent to a lab for actual testing for COVID-19.
According to Everywell, "Our COVID-19 partner labs are CLIA-certified labs—many of which already offered infectious disease assays, including tests for other respiratory viruses. Many of these labs also already conduct diagnostic COVID-19 tests for hospitals and clinics in their regions."
Companies like Everywell have the existing diagnostic capacity, but the FDA is concerned with the integrity of at home specimen collection. The agency worries that patients won't be able to adequately collect samples with the potential to lead to false negatives.
In response to these concerns, a Texas-based company called MicrogenDX has validated a laboratory test that can detect the virus through coughed up saliva.
"Collecting a nasal swab, should be done by a health care provider because it really should go deep into the sinuses, but there is no health care provider involved in sputum collection," MicrogenDX CEO Rick Martin said in an interview with ABC News.
MicrogenDX is set to launch a new service where patients could directly request a COVID-19 kit online at home. While patients may have the option to send their saliva samples from the comfort of their own home, MicrogenDX says they are not a home collection kit. They say a physician must first authorize the test before a patient can order it online.
"It's up to the physician and the patient where they are going to collect that specimen," said Martin.
Javitt says this system -- a physician-prescribed at-home test, rather than one you order directly as a consumer -- falls into a regulatory "gray area."
"The FDA does not regulate the practice of medicine; they regulate product, and so once a physician has made a decision to send a kit there is some ambiguity where FDA authority would end," she said.
"At this point, I'm not allowing patients to order kits as a test kit. I'm allowing physicians to order them to be sent to patients," Martin said. If a patient wants a test they must receive a signature from their doctor. Once the doctor approves, the patient will receive an online code that will allow them to order the test online.
MicroGenDX's kit would cost $125 with a $10 shipping fee. Patient samples would be shipped overnight to their main lab in Lubbock, Texas, and receive their results through their doctor the following morning.
"We want maximal flexibility, within the bounds of what's feasible in the current FDA regulatory regime in order to get as many of these tests into people's hands as possible," said Adalja. Home test collection kits may be key in doing so, but as health and federal authors face an unprecedented public health emergency the regulations are working on catching up with the needs.
The Bill and Melinda Gates Foundation is working with Amazon, for example, to offer home COVID-19 testing kits to people in the Seattle area, an area that has been particularly hard hit with COVID-19 cases. This initiative -- which is also supported by the University of Washington -- is meant to increase access to testing and help public health officials learn more about how the virus spreads.
Adalja notes that even outside the current COVID-19 pandemic, advocates and public health experts have been pushing for better access to at-home testing.
"The coronavirus pandemic, which has been marked by lack of diagnostic capacity, will underscore the need for these types of tests available in general," he said. "This will give us a pathway to increase diagnostic capacity very rapidly and also keeps people out of hospitals, doctors offices, emergency departments where they could potentially infect other people and create crowding."
Copyright © 2020, ABC Audio. All rights reserved.
iStock(NEW YORK) -- When Dr. Darien Sutton saw what was happening in Italy, he braced himself.
Sutton, an emergency medicine physician in Queens, New York, anticipated that the reality in Italy during the novel coronavirus pandemic -- not enough hospital beds, a lack of protective gear -- would soon become the reality in the U.S.
In New York City, he was right.
"Right now, looking at a large hospital in Queens, the medical intensive care unit is already at capacity," Sutton told ABC News on Friday.
He hopes it will serve as a wake-up call for other communities throughout the country on how to respond.
"We should use this as an igniting event," Sutton said, encouraging other communities to test early and actively push for social distancing even if they aren't in a dire situation right now.
Currently, there are more than 100,000 confirmed cases of COVID-19 in the U.S. and at least 46,000 in New York. More than 26,000 of the state's cases are in New York City and at least 450 city residents have died. A breakdown of where the cases are shows that the areas with the most patients testing positive are in six neighborhoods in Queens and nine neighborhoods in Brooklyn.
The city's density has helped aid the spread of the virus, according to health experts. There are 27,000 people per square mile, the densest metropolitan area in the U.S.
"As soon as a virus that is this transmissible gets into a population density that's this urban, you're gonna see exponential growth," Dr. Eric Cioe-Peña, director of global health at Northwell Health, told ABC News.
In Queens, Sutton said there has been a higher rate of cases than in the other boroughs because it's home to two major airports -- John F. Kennedy International Airport and LaGuardia Airport -- and because many residents there don't have access to health care.
"What we've seen is that when you don't have instructions, medical care or help, you increase the likelihood of transferring it to other people in your community," he said. "If you're looking at New York City, you really have to get into the grid."
Health experts also noted that the numbers in New York are just a snapshot of the virus' spread.
The rate of testing has to be accounted for, as well. Gov. Andrew Cuomo has said that New York is completing more testing than other states, leading to a rise in the numbers.
And with all eyes on the city, more people are aware of the situation and residents may seek out testing at higher rates than in other areas, according to Dr. Jon Zelner, an associate professor of epidemiology at the University of Michigan.
Heightened anxiety around coronavirus in the city is certainly on the rise. On Thursday, the New York City Fire Department handled more than 6,000 911 calls, on what was the busiest day ever for FDNY paramedics in terms of individual medical incidents, according to the department.
The record-high call volume was largely driven by calls from people who are scared or concerned they have coronavirus.
There are more than half a million health care workers in the city, according to a report released by New York City Comptroller Scott Stringer. He feared that many didn't have the proper equipment, noting that he heard stories from nurses who have only one mask because there aren't enough to go around.
Stringer also noted that these workers are ones who "are too often ignored, underpaid, and overworked."
Though they are the ones protecting the city, 18% are living below twice the poverty line, according to city data. The New York City poverty threshold was $33,562 in 2017.
As for hospital beds, there were 53,000 hospital beds, but Cuomo said the city would need 143,000. ICU beds were also lacking. The 3,000 currently in place don't match up to the predicted 40,000 needed, according to Cuomo. The USNS Comfort and a military hospital established at the Javits Center are both expected to take non-COVID-19 patients soon in order to free up beds in the city for those who are sick.
Sutton said the notion that there is equal need across all five boroughs is a misconception.
In Queens, there are just 1.5 beds for every 1,000 people. But in Manhattan, there are 5.4 beds for every 1,000 people, according to Sutton.
"This is a humongous difference," he said.
Those differences need to be taken into account when looking at the city as an example, Sutton said.
And as the city continues its uphill battle in facing the pandemic, Sutton pointed out that other communities could soon experience the same suffering.
"It's a mess. It's really a mess," he said. "You may walk around being naive. I just want you to know that we are already at a point of critical mass."
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iStock(NEW YORK) -- In the months since the novel coronavirus exploded into a pandemic, we have heard a range of stories about those who have been stricken by the disease -- the vast majority with mild symptoms, but an increasing number needing to be hospitalized.
But what about those who were reported to have recovered from the illness, which has no inoculation or cure?
While the telltale symptoms of coronavirus, including fever, dry cough and shortness of breath, have been well-publicized, there's been less information about the long-term health of people who contract COVID-19 and recover.
In part, that's because the virus is new. The first cases emerged in Wuhan, China, in December, so even the very first people who contracted COVID-19 and recovered are less than six months out from when they were initially infected.
Roughly 80% of COVID-19 cases reported in China, were considered mild, according to the CDC.
Dr. Shu-Yuan Xiao, a pathology professor at the University of Chicago School of Medicine, stressed that most patients who have mild illness should recover "with no lasting effect."
Patients who have a more severe illness, but recover without needing to be put on a ventilator, should also be free of long-term side effects, he added.
"For the 16-20% of symptomatic patients who eventually need ICU care, it is difficult to predict," he said, referring to the percentage of those hospitalized who will need critical care.
Patients who go into the intensive care unit and need ventilators are more likely to have lung damage, and to develop acute respiratory distress syndrome (ARDS), a severe lung condition in which fluid collects in the lungs' air sacs.
"Based on experience from SARS and MERS, some patients may develop lung fibrosis," Xiao said, though he noted that lung fibrosis, which is when lung tissue becomes scarred, has not been observed in the limited studies we have so far about COVID-19.
"In China, some patients eventually needed to be on [an ECMO life-support machine], to temporarily support the patients while they regain lung function," he said. "However, some of them [may] never regain lung function."
According to a study published in the Journal of the American Medical Association published in February, which examined 138 patients in Wuhan, China, 10% of those in ICU care were eventually switched to ECMO machines, which remove the blood from the body, oxygenate it and then return it to the body.
While those long-term effects sound frightening, the reality is that lingering health consequences among people who contract severe respiratory diseases are common.
"It’s the same general thing that you have with any type of phenomena that's severe enough to land you in the ICU," said Dr. Amesh Adalja, an infectious disease and critical care expert at Johns Hopkins Bloomberg School of Public Health.
"There’s a lot in common with what we do for non-COVID respiratory failure that’s going to be applicable here," Adalja said.
For people who are put on a mechanical ventilator, it's likely to be several months to a year before they recover full lung function, he explained. Some may never recover that functionality.
"It’s not a one-size-fits-all situation," Adalja said. "How much lung tissue was destroyed by the virus? That would translate into having increased shortness of breath."
Both Xiao and Adalja emphasized that much more research is needed before we know how recovered COVID-19 patients severe disease fare months or years out.
"I hope there [will] be more autopsies performed on patients who died of the disease, to provide better knowledge," Xiao said.
"Currently, we know so little about the spectrum of COVID-19 pathology."
Despite those figures, "severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19," the report notes.
The long-term effects of being put on a ventilator could become a reality for hundreds of thousands of Americans. The Society of Critical Care Medicine projects that as many as 960,000 Americans may need to be put on ventilators during the course of the outbreak in a worst-case scenario.
That doesn't mean everyone who needs a ventilator will get one.
As it stands, Johns Hopkins Center for Health Security estimates that there are only 160,000 ventilators currently available for patient care, and 8,900 in the national stockpile.
Copyright © 2020, ABC Audio. All rights reserved.
iStock(NEW YORK) -- As health experts and public officials have warned that confirmed cases of the novel coronavirus are likely nowhere near the actual number of people infected, medical professionals in Boston have created a website to help close the gap.
"COVID Near You" allows the public to report coronavirus-related symptoms. The site asks users how they are feeling with the options of "Great, thanks!" and "Not feeling well" as answers.
Those who answer that they're not feeling well are asked to identify their symptoms and answer a series of questions, such as when they began to feel ill, if they have been in quarantine or isolation and whether they have traveled outside of the United States.
Dr. John Brownstein, an epidemiologist at Boston Children's Hospital who helped develop the website, said that with more data it would be easier to identify emerging hotspots.
He told ABC News that most people experience mild illnesses, so they often won't go to a health care provider.
"It's so important to understand the mild illness," said Brownstein, an ABC News Medical Unit contributor. "A mild illness in the community ... that is what ends up leading to more complicated issues."
There are more than 590,000 cases of coronavirus, or COVID-19, in the world, and at least 26,943 people have died, according to data compiled by Johns Hopkins University.
A map on the website shows the number of people in the U.S. who have reported experiencing coronavirus symptoms, which can range from mild, like a slight cough, to more severe, including fever and difficulty breathing, according to the Centers for Disease Control and Prevention.
The website was created by employees at HealthMap, a medical data tool at Boston Children's Hospital, and is similar to one developed to track the flu.
While Brownstein noted that it was possible for false information to slip through the cracks, they have established protections to limit it.
"COVID Near You" collects a zip code and IP address from those who use it, which, Brownstein said, make it easier to determine if one person is continuously entering incorrect data.
And while the site has limitations -- it will not give someone a diagnosis of coronavirus -- Brownstein said he believes local officials will find it a very useful tool.
"We're putting the 'public' back in public health," he said.
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narvikk/iStock(NEW YORK) -- It's a critical, urgent question in the battle to save American lives -- and one that a growing number of institutions, including one of New York's preeminent medical centers, will attempt to answer.
Dr. David Reich, the president of Mount Sinai Hospital in Manhattan, said his team of experts is in the process of tracking down possible donors -- recovered patients whose blood antibodies could potentially curb the virus in the sickest patients.
“It’s great that we have some avenues and some options to try to improve the treatment of our patients,” Reich said in an exclusive television interview with ABC News' Diane Sawyer. “And we certainly hope the crisis in New York will abate soon and that we can save as many people as possible from this terrible disease.”
With an approved vaccine still months away at best, the experimental treatment offers a ray of hope for medical professionals and patients alike. The premise is simple: plasma isolated from blood donated by those recovered patients is transferred to a sick patient using an IV, which may then boost a patient with COVID-19's own defenses.
“Am I right that you are about to see if the antibodies of a recovering person can save the life of someone who is critically ill?” Sawyer asked.
“That is concept, Diane,” Reich said. “The idea is that -- as has been done in multiple previous epidemics -- if you give the plasma, the portion of the blood that contains the antibodies, from someone recovering from an illness, a viral illness like COVID-19 or Ebola -- it may help the patient overcome the disease.”
The practice is called convalescent plasma, and medical professionals in China have already used it on at least five critically ill patients with COVID-19, according to results published Friday in the Journal of the American Medical Association (JAMA).
The clinical data in China shows the five patients were in critical condition before the plasma infusion. Afterwards, according to the study, they began to recover.
“These preliminary findings raise the possibility that convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS, but this approach requires evaluation in randomized clinical trials,” the JAMA study concluded.
Mount Sinai is not alone in this endeavor. A group of the nation’s top academic institutions recently launched a website with protocols for those interested in experimenting with convalescent plasma. A spokesperson for the Food and Drug Administration said Friday that a small but growing number of institutions are developing protocols for the procedure.
“We believe it can be disease-modifying and reduce duration and severity in some patients,” said Dr. Michael Joyner, a physiologist and anesthesiologist at the Mayo Clinic, one of the institutions mobilizing to start this.
Healthcare providers in the United States are optimistic, but the experimental therapy will take time to fully develop and is not without risk – and should not be perceived as a “magic bullet,” Reich warned.
“We can never know with a new therapy if we’re causing more good than harm or more harm than good, and that’s going to be always a concern for us, but we believe based upon the history of this therapy that it is the right and ethical and moral thing it to do in the face of a growing crisis,” he said.
Even so, Mount Sinai and others are moving forward. Reich said his team will aim to begin convalescent plasma treatments in the coming days, but the first order of business for medical staff is to find recovered patients – ideally those with a particularly high antibody count that could support more than one current patient.
A lab team at Mount Sinai has been working around the clock in recent days to find candidates, according to Reich. Prospective donors must be at least 21 days removed from the initial symptoms and be able to provide documentation of a positive case.
So far, the community has responded: the hospital says it has already received thousands of offers to donate blood. One of those recovered patients is 31-year-old Rich Bahrenburg.
“It feels like at least if I have to go through this and I’m one of the lucky ones who doesn’t have to be on a ventilator, one of the lucky ones who doesn’t have to be at the hospital, I feel like I owe it to people as a whole to try and give back if I can,” Rich told ABC News.
Reich and his Mount Sinai team are hoping others like Rich follow suit.
“I think that it’s beautiful if people who are recovering from the illness can, in the spirit of donation and helping others -- that some of them will have that capacity in having very high levels of immunity,” Reich said.
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iStock(NEW YORK) -- Iran, already struggling to fight the growing spread of novel coronavirus, is now coming to grips with an alcohol poisoning problem that has killed hundreds of people this year.
In the wake of the deaths, officials initially blamed misinformation on social media for convincing victims that drinking alcohol could protect them against coronavirus. But a change in explanation from doctors is opening eyes to a larger problem of bootleg alcohol in the country.
"The first few days we all thought patients had drunken alcohol to protect themselves of corona, as some of them claimed so," Gholam Hosein Mohebbi, head of the public relation of Imam Hospital of Ahwaz, told ABC News.
"But later we realized from their families and friends that they were mostly alcohol users who would get their alcohol from bootleggers, but this time what they had been handed over was a methanol-based drink, not their usual booze, named araq, mixed with water and ethanol," he added.
Trading and drinking alcohol is illegal in Iran, and those seeking alcoholic drinks often rely on a chain of black market dealers without knowing where and how the drinks are produced. The dealers themselves are often not sure of the source of the alcohol.
"One of those [who] died of poisoning in our hospital was an alcohol dealer," Mohebbi said, cautioning people not to trust anyone selling alcoholic drinks and pleading on behalf of a medical staff already overwhelmed with coronavirus infections.
At least 2,197 people have been poisoned by alcohol across the country since the first reported cases of coronavirus in early February and 244 had died as of Sunday, Tasnim News Agency reported.
Iran is already reeling from the coronavirus pandemic; it is the hardest hit country in the Middle East.
The country has an official death toll of 2,378 from 32,332 infection cases, the spokesman of the health ministry, Kianoush Jahanpour, said on Friday, according to the Iranian Students' News Agency.
The rising number of poisoning casualties alarmed other alcohol users to avoid trusting their former dealers.
"People are afraid of buying booze from their dealers," said a 29-year old student who did not want his name to be mentioned for security reasons. He lives in Ahwaz, the capital of the province of Khuzastan, which ranks second in the number of alcohol poisoning casualties. The shortage and increasing price of ethanol has led some producers to end up adding poisonous methanol to the drinks instead of drinkable ethanol, he believes.
"My friend has started making alcohol at home after he lost a friend to poisoning earlier this month," he added.
However, making alcohol at home can also be dangerous.
"If you are unfamiliar with the process, you might end up poisoning your own stuff with a minor mistake. That's why I can't trust his first products," the student said. He said he rejected his friend's invitation to a drink at his place.
"I said no, but can't stop thinking about him as he is an alcoholic and can't just quit easily, especially now with so much free time he has under quarantine," he added.
Mohebbi expressed his concerns about people with alcohol problems, too.
"We know that those who have alcohol problem[s] have a tough time, but it is banned in our religion. I hope they try to stop drinking at least for now," Mohebbi said.
Despite the illegality of drinking alcohol, those who are poisoned and taken to the hospital are not being prosecuted or arrested, Mohebbi emphasized.
"As medical staff, we are loyal to our duty, which is treating everyone. It doesn't matter if a patient is poisoned by alcohol or is infected by corona," he said. However, to reach the main sources of methanol contamination, police ask questions from the patients.
"Police does not pressure the patients at all. They just try to gain as much information as they can to find the source and prevent more casualties," Mohebbi said.
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The USNS Comfort takes on fuel and supplies in preparation to deploy in support of the nation's coronavirus outbreak, March 25, 2020. (U.S. Navy) (NEW YORK) -- To help medical professionals focus on treating novel coronavirus patients, the Navy has deployed two hospital ships, to New York and to California, that will be used to treat people suffering from other ailments.
The United States Naval Ships Mercy and Comfort each are 894-foot vessels stocked with life-saving equipment.
As of Thursday, California had almost 800 confirmed cases of COVID-19 and New York State had over 30,000, including more than 17,000 in the five boroughs.
The USNS Mercy’s medical treatment facility has a medical crew, officials said, from the "Navy's Bureau of Medicine and Surgery responsible for operating and maintaining one of the largest trauma facilities in the United States."
USNS Mercy left San Diego for Los Angeles earlier this week, and USNS Comfort will head to New York Harbor from Norfolk, Virginia, by March 31.
What's inside these floating hospitals?
- Up to 1,200 Navy medical and communications personnel and more than 70 civil service mariners.
- Up to 5,000 unit of blood
- 12 fully equipped operating rooms
- 1,000 patient beds
- 8 Intensive Care Unit beds
- 4 radiology suites
- 2 oxygen-producing plants
- 1 isolation ward
Both ships also are equipped with digital radiological services, a medical laboratory, a pharmacy, an optometry lab and a CAT scan. They also have a helicopter deck capable of landing large helicopters and side ports to take on patients at sea.
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Halfpoint/iStock(NEW YORK) -- As more people across the United States test positive for the novel coronavirus, or COVID-19, it's important to know what to do if you think you have the virus.
If you develop mild flu-like symptoms, call your doctor or your local health department and mention why you think you may have COVID-19, said Dr. Jennifer Ashton, ABC News’ chief medical correspondent.
Your doctor can work with the state and the Centers for Disease Control and Prevention (CDC) to decide if you should be tested.
It's important to call your doctor and not just go into a doctor's office without an appointment, the CDC said. That's because it'll give your health care provider the ability to keep other people there from being exposed.
You should get help immediately if you have trouble breathing, persistent chest pain or pressure, new confusion or bluish lips or face, according to the CDC.
If you are mildly sick with COVID-19 symptoms you can isolate at home, the CDC said. It's important to wear a mask at home and separate yourself from the others who live there.
Always cover your mouth and nose with a tissue when you cough, sneeze or blow your nose and then immediately wash your hands with soap and water for at least 20 seconds, the CDC said. Make sure to clean "high-touch" surfaces daily, like counters, computers, phones, toilets and doorknobs, the CDC advises.
Those with COVID-19 who are isolating at home can leave the house once they have accomplished these three things: at least one week has passed since symptoms started; symptoms have improved; no fever for at least three days without medicine that reduces fevers, the CDC said.
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FilippoBacci/iStock(NEW YORK) -- Even with businesses closed, travel restricted and shelter-in-place orders issued around the world, many still wonder if such extremes are needed to battle the novel coronavirus.
Some people, including the president of the United States, have said COVID-19 isn't too different from the common flu.
But, according to experts, is COVID-19 actually worse?
The short answer? Yes.
An estimated 35 million Americans were infected last flu season, and about 500,000 were hospitalized. Approximately 35,000 died.
Even with more than 10% of the U.S. population affected by the flu most years, those are stunning numbers. But businesses aren't closed and people aren't asked to stay home.
What's different now?
COVID-19 in a novel virus, which means it's new. Although similar to SARS and MERS, it's wrong to assume it will follow the same path as its coronavirus cousins -- indeed, COVID-19 already has spread far beyond either of them.
So although the seasonal flu, at least to this point, has killed more Americans, COVID-19 appears more deadly and definitely spreads more quickly.
In other words, experts told ABC News, it's not the seasonal flu.
So exactly how much worse is it? Consider this chart, which compares COVID-19 to the flu using the most recently compiled statistics.
ABC Photo Illustration
It's still unclear exactly how deadly novel coronavirus is. The death rate may be overestimated because testing hasn't been ramped up and there could be hundreds of thousands or even millions not counted globally because they never get sick or show symptoms. The death rate, at least so far, similarly could've been affected by variables that have nothing to do with the virus itself, including overwhelmed hospitals, which contributed to Italy's estimated mortality rate of about 7%.
Perhaps most important, COVID-19 remains extremely dangerous because so many people show minimal or no symptoms -- a phenomenon often called "a silent infection." This can accelerate person-to-person transmissions because carriers of the virus simply don't know they have it.
"This disease seems to respond to social distancing, and so we can help reduce the number of people dying of COVID-19," said Dr. Pritish Tosh, medical director for Emergency Management at the Mayo Clinic. "This is not overhyping. These rather unprecedented social maneuvers are likely to help to keep otherwise vulnerable people from getting sick and dying."
More pronounced symptoms tied to COVID-19 probably would have slowed its spread.
"In general, when the flu hits you, people lie in bed and don't go out," said Dr. Simone Wildes, an infectious disease specialist at South Shore Health. "But something we are seeing with COVID-19 is that because the symptoms are mild for most of the population, they can go out and spread the disease quite easily, especially given how long you can be infectious for."
Fortunately for most patients, COVID-19 infections have proven mild, but current statistics still support recent statements by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and White House Coronavirus Task Force expert, that COVID-19 is over 10 times as lethal as the flu.
Although they could quickly change, current data paints a morbid picture.
Especially because there isn't a current treatment.
Especially because there isn't a vaccine.
Especially because no one's really sure how this pandemic will unfold.
Copyright © 2020, ABC Audio. All rights reserved.
Adene Sanchez/iStock(NEW YORK) -- Early in the novel coronavirus pandemic, encouraging data suggested that infants born to mothers with COVID-19 did not acquire the virus before birth, a process called vertical transmission. However, three new reports released in The Journal of the American Medical Association unfortunately suggest the opposite may be true.
Vertical transmission, or the spread of infectious disease from mother to child, initially seemed unlikely based on initial COVID-19 case reports as well as historical data from the outbreaks of MERS and SARS, close cousins of the novel coronavirus. To date, data has been published on 19 infants born to mothers with COVID-19, all of whom subsequently tested negative for the virus.
However, a study released from Wuhan’s Children’s Hospital evaluated 33 newborns born to mothers with COVID-19 pneumonia, finding that three of these infants (9%) fell ill. The physicians involved noted that strict infection control procedures were followed during delivery, suggesting that the virus didn’t infect the infants during or after delivery, and instead likely came from the mother while they were still in the womb.
Fortunately, all three infants pulled through. Two of the infants were born full-term via C-section and developed fever, lethargy and pneumonia on chest radiographs. The third infant required more intensive care, but was also significantly premature -- born at only 31 weeks gestation, or six weeks early.
The premature infant also was found to have sepsis, or a blood infection caused by a bacteria. With this, along with the complexity that inherently goes along with prematurity, it is unclear how significantly COVID-19 affected the infant’s health. Fortunately, respiratory support and antibiotics led to improvement and recovery.
Antibodies in newborns raise further concern
The two additional research letters released on March 26 report a different sign of potential mother-to-child transmission. In a bit of a medical mystery, researchers describe case studies of three infants that did not have symptoms nor test positive for active COVID-19 infections, but did have specific antibodies, or immune proteins, called IgM.
IgM is usually produced in response to a pathogen three to seven days after infection. It is not usually transferred from mother to fetus because of its larger structure, which is too big to cross the placenta.
Researchers suggest that if coronavirus-specific IgM is present at birth, it could either indicate that the infant had produced its own IgM in response to the virus or the mother’s IgM was transferred to the baby through a damaged placenta.
The first of these case reports reviewed the laboratory results of six pregnant women with mild COVID-19 who were admitted to Zhongnan Hospital of Wuhan University. All gave birth via C-section using multiple infection control measures, including isolation of their infants immediately following delivery. Two of these six infants had IgM present, but none had symptoms and were repeatedly negative when tested for the virus.
A separate report from Renmin Hospital of Wuhan University had similar findings, but focused on only one infant. This mother was sicker than the others and was treated with antiviral, antibiotic, corticosteroid and oxygen therapies. She gave birth via C-section nearly one month after contracting the virus and her infant, too, was positive for coronavirus-specific IgM.
While these findings are difficult to interpret given their paucity of accompanying clinical details, these isolated case studies are still worthy of special attention.
Scientists and researchers are still studying these cases to see if they offer any clues about how to best protect the health of infants and mothers with COVID-19 infection. Until we have more data, pregnant women and women hoping to soon become pregnant should continue to seek guidance and medical care from health professionals.
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LucaLorenzelli/iStock(NEW YORK) -- After spending time apart social distancing, and witnessing the devastation caused by the coronavirus crisis, many may also just miss simple social interactions.
Whether it's going for a cup of coffee, taking a stroll and sparking up conversations with a friendly dog owner or enjoying a meal with friends, even mundane moments of once daily routines feel like a luxury people are already eager to have back.
Keeping a safe distance has been an imperative for public safety during COVID-19, but it's OK to feel nostalgic for life's little moments that have temporarily fallen by the wayside.
Dr. Ilyse Dobrow DiMarco, a clinical psychologist and author, told ABC News it's "absolutely" normal to miss all the things we had going on in our lives.
"We humans thrive on predictability and routine. Even things like taking the same route to work or seeing the same people at our weekly Zumba class provide us with a sense of comfort," she explained. "We know what to expect, and that helps us feel in control."
As for why we feel so jolted by the sudden and seismic societal shift, DiMarco said, "anxiety is all about uncertainty and once you start removing certainties from people’s lives -- people start to feel unmoored."
Since the days, weeks and months ahead are still uncertain, DiMarco suggests people make a list and write down all the things they want to do when this is all over.
"I encourage them not to think of a timeline for these things but rather to think of it as a 'bucket list,' to be tackled whenever life resumes as usual," she said, adding that it's good to plan for "the first restaurant they will eat at and park they will visit once normalcy returns."
Here's a snapshot of some of the things people miss from everyday life and look forward to taking full advantage of once again when the pandemic is in the rearview:
Hugging friends and family
Aside from being able to just see family and friends in person, many people really miss the warm embrace that comes with a greeting or goodbye between loved ones.
Whether it's attending your favorite professional sporting events, playing a pickup game of hoops with friends or watching a live game on TV, people around the country have felt the weight of missing out on what has always been a fun, entertaining pastime.
Baseball fans struck out on Thursday since MLB postponed Opening Day; the NBA season is temporarily suspended; the NCAA March Madness tournament was canceled and the 2020 Summer Olympics in Tokyo have been postponed.
Going out to eat
Many people are missing the experience and excitement around Sunday brunch, a weeknight dinner at an undiscovered restaurant or even strolling into your favorite neighborhood spot for a quick bite.
As everyone resorts to cooking at home or ordering takeout, the idea of sitting down for a meal, prepared by chefs in a professional kitchen sounds like a dream.
Meeting up for coffee or drinks
Baristas and bartenders miss you as much as we miss them.
Grabbing an afternoon coffee with your co-worker or meeting up with friends for happy hour in person has been a widely missed ritual.
While people have gotten creative with virtual happy hours and hangouts, we can all add raising a glass to our health and routines whenever those activities can resume in person.
Fitness classes, the gym and working out
Yoga, pilates, spin, swim, Zumba, boxing, running, weightlifting -- you name it -- people miss it. With gyms closed in most places, people have had to reinvent their workout routines where they can.
From group fitness classes to running clubs, making it to your mat or cruising through a finish line with a huge crowd after 13.1 miles -- working out has also taken a turn.
While some people have jokingly seemed shocked by the notion that they miss working out, many have had an epiphany that the absence of physical activities really does make the heart grow fonder.
Instructors have gotten creative by bringing so many of their workout routines to virtual platforms online, but performing bodyweight moves in a studio apartment doesn't exactly hit the same levels of intensity as a high-octane, fast-paced HIIT class.
Going to work
In what has felt like an eternal Sunday for some folks, there are millions of previously employed Americans who have lost jobs across a multitude of different industries that have seen a sharp decline in operations due to coronavirus. The service industry was among the hardest hit -- particularly foodservice and hospitality.
Restaurant and bar owners, chefs, managers, sommeliers, hostesses, servers and more have banded together to raise funds for their impacted community.
For those fortunate enough to still be employed, many Americans wish they could go into their respective place of work. Be it behind a chef's counter of a busy kitchen or a desk inside an office building, lots of folks miss the daily social interactions with co-workers and getting their jobs done where the magic is meant to happen.
"Even patients who formerly complained about their desk job now wax sentimental about their cubicles, because at least those cubicles were next to other people’s cubicles," DiMarco said. "Now, they’re totally by themselves at their desks at home and truly craving the cubicle-to-cubicle interaction."
Sure, preschoolers may not think twice about remote learning, but lots of teachers and students alike are missing the classroom. And probably a few thousand parents too, who have had to adjust to take on both work-from-home and teach-from-home double duty.
"I walked both my sons to elementary school every single school day this year, not thinking twice about it, and now, I miss it desperately," DiMarco said of her own top missed activity.
Grocery shopping in peace
No panic buying in bulk or seeing rows upon rows of empty shelves, but seeing people calmly pick up all the products they need, when they need it and get in a normal-sized line to pay for it.
Making memories big and small
Milestones have been missed -- weddings canceled, funerals forgotten, family reunions postponed, half-marathon races restricted and more daily interactions for people to cherish that were supposed to happen and didn't.
Di Marco suggests tapping into the various virtual options right now.
Using Zoom, FaceTime or Skype to create hangouts, workouts, happy hours and birthday parties are all great options, she said.
"I think the key is to think through the things that you miss and consider how you can recreate them virtually," DiMarco explained.
She also said it's a good idea to stretch the legs and get outside.
"There’s always the neighborhood walk/bike ride," she said.
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BartekSzewczyk/iStock(NEW YORK) -- If drugs can be famous, chloroquine is as close as it comes.
Chloroquine, and its derivative hydroxychloroquine, were touted by President Donald Trump as potential “game changers” when combined with azithromycin, and were elevated to stardom practically overnight. Previously approved as anti-malarial drugs, for systemic lupus erythematosus and rheumatoid arthritis, these drugs are now used by some front line clinicians “off-label” for their patients with severe illness from COVID-19.
The “off-label” use means the medications have not been adequately tested or approved for that specific disease or illness. So why would clinicians risk it and why would politicians prematurely praise it?
For now, there is no approved treatment, vaccine or cure for COVID-19. With confirmed cases of COVID-19 surpassing the half a million mark worldwide, clinicians all around the world are learning from each other’s experiences and drug cocktails, trying to give their patients the best chance they can.
Dr. Michael J. Ackerman, Mayo Clinic genetic cardiologist and director of the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program, explains that one of his colleagues described the consequences of using medications “off-label” for COVID-19 as "friendly fire."
They throw everything at it and hope the benefits outweigh the risks. However, Ackerman explains that it may have led to the Wild West, where “drugs are being used without proven therapeutic efficacy- based on hope and promise.” He says he does believe they may work, but emphasizes the need for “rational, careful, prudent guidance.”
Guidance is particularly paramount for chloroquine and hydroxychloroquine because of a known side effect: drug-induced arrhythmias from prolonged QTc intervals that can be detected by echocardiogram. In rare cases, your heart can stop and you can die.
“How do we navigate while we’re waiting for clarity on the drug’s therapeutic efficacy? How do we respect this unwanted side effect, which happens to not just be lightheadedness, dizziness and tingling fingers, but sudden death?” said Ackerman.
To answer these questions, Ackerman and his colleagues set out to create a clinical algorithm to help determine each patient’s risk.
The risk categories they developed put people into three groups, simplified as ‘green light’ for low risk, ‘yellow light’ for moderate risk, and ‘red light’ for high risk. Having a high risk for drug-induced arrhythmias doesn’t automatically mean you shouldn’t take chloroquine and hydroxychloroquine. But it does mean that your doctor should carefully weigh the risks versus the potential benefits.
"If we know their QTc, they are going to be ‘green light,’ go! There is going to be tremendous safety margin with these medications for 90% of the patients," said Ackerman.
"For 5 to 10%, they’re going to be in a caution light, a ‘yellow light’ because they are already showing that they’re kind of on the high edge of normal of the QTc even before we add these medications, and for 1% they’re going to already be at the ‘red light,’ be very, very careful. The risk-benefit balance better be there, and if we still think we should proceed, we better do what we would call our QT sudden cardiac death countermeasures preemptively,” he said.
If the patient needs the medications, there are ways to reduce the risks such as correcting electrolyte abnormalities, discontinuing other medications that could cause problems if taken at the same time as hydroxychloroquine, keeping patients on heart monitors, or asking them to wear an external defibrillator.
Ackerman fully expects the use of hydroxychloroquine to skyrocket. In fact, there are already reports of patients who take the drug for its other approved purposes, such as rheumatoid arthritis, not being able to get their medication at the pharmacy.
If these medications get approved for COVID-19, “we’re going to be seeing hundreds and hundreds of thousands of people, potentially millions being put on these medications. When you scale it up to that level, this unwanted side effect which happens to be a big deal is going to show itself, and it’s going to show itself in a significant way," Ackerman said.
Ackerman thinks that the best initial defense is turning the QTc value into a global vital sign.
“Just like a diabetic needs to know or does know his or her glucose, this QTc value is essentially a vital sign," he said.
Knowing your QTc interval is not only important for COVID-19 treatment, but also because of countless other medications that exist.
“This isn’t the only scenario where the medication inadvertently, suddenly killed the patient because of drug-induced long QT syndrome and drug-induced sudden cardiac death,” Ackerman said.
In fact, he points out that “the single most common reason why a drug gets removed from development or market is drug-induced sudden cardiac death because of drug-induced long QT syndrome.”
QTc is undoubtedly an important way to screen patients with COVID-19 who might be good candidates for the experimental hydroxychloroquine, but this may pose a challenge. Administering an ECG to patients with COVID-19 would mean a technician would risk exposure and use precious personal protective equipment for each ECG that was needed, according to Ackerman.
For now, by not screening patients with COVID-19 before starting these medications, doctors are effectively shooting in the dark.
Fortunately, the Food and Drug Administration approved a personal ECG device that would allow accurate ECG recordings (and therefore QTc calculations) to be taken by patients on their smartphones without potentially exposing a technician to COVID-19 multiple times.
By understanding everything about a patient, their risk factors, their medications, their vital signs -- in this case their QTc interval -- doctors can use the model to pinpoint a patient's risks versus benefits, and treat them with more accuracy. Broadly speaking, doctors refer to this concept as "precision medicine," meaning they try to tailor each treatment to make it unique for each patient.
Ackerman, who has spent the last 20 years of his career focused on patients with congenital prolonged QT, believes “that this is the time to really put precision medicine into action. It has been a buzz phrase for too long. And now I think we’ll see how well can actually do this. We know our patient’s profile, we know the drug’s profile, we try to see if we can match that and really do precision medicine. I think we can. I mean, we should be able to. We have the knowledge, we have the technology, we have the ability.”
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