Updated on Sep 29, 2023 | COVID-19, Your Health
The Biden administration recently announced that it is making four more COVID-19 antigen tests, also known as rapid tests, available to each U.S. household for the fall of 2023. You can order your tests through the federal government’s COVID.gov website.
A positive result on one of these tests is a reliable indication that you have COVID-19, especially when you are also experiencing symptoms like fever, cough, or shortness of breath, says Bernard Camins, MD, Medical Director of Infection Prevention for the Mount Sinai Health System.
Dr. Camins says that if you test positive and have symptoms, you should schedule a follow-up virtual or in-person visit with a health care provider, especially if you are at high risk for complications. The provider can prescribe an antiviral medication like Paxlovid™ (nirmatrelvir/ritonavir), which can help if taken within five days after your symptoms begin. The medicine works by stopping the virus from multiplying in the body.
(The Centers for Disease Control and Prevention (CDC) also recommends that if you test positive, you isolate from other people for five days or until your symptoms improve, whichever is longer. If you need to be around other people during this time, wear a high-quality mask.)
A negative rapid test does not necessarily mean that you do not have COVID-19, Dr. Camins says. Especially if you have symptoms, a negative test may just mean it was too early to detect the virus.
The Food and Drug Administration (FDA) recommends that people who have COVID-19 symptoms and test negative on a rapid test take another test 48 hours later. If you were exposed to COVID-19 but do not have symptoms, the FDA recommends that you test three times, with 48 hours between each test.
You can also take a laboratory test called a polymerase chain reaction (PCR) test, which is more reliable than a rapid test but must be given at a medical office. Mount Sinai Health System offers several ways to get a PCR test in the New York metropolitan region:
- If you do not have any symptoms but need a test, contact your primary care provider or find a test site near you.
- If you need a test due to mild symptoms, our Mount Sinai Urgent Care locations throughout New York City accept both walk-in and scheduled appointments 365 days a year.
- Please wear a mask and practice social distancing. It is especially important to wear a face mask on the way to your appointment to help prevent the spread of any respiratory virus you may have.
Updated on Sep 13, 2023 | COVID-19, Featured, Your Health
Respiratory viruses, such as influenza and respiratory syncytial virus (RSV), tend to pick up during fall. On top of that, COVID-19 is still circulating, with cases increasing in recent weeks. To fight off what some are calling a “tripledemic” of all three viruses, state and federal health officials are urging people to protect themselves with vaccines.
In an interview, Bernard Camins, MD, Professor of Medicine (Infectious Diseases), and Jennifer Duchon, MD, Associate Professor of Pediatrics (Newborn Medicine), at the Icahn School of Medicine at Mount Sinai, provided additional background about vaccines that will be available this fall.
COVID-19
COVID-19 cases and hospitalizations are not as high as they used to be at the height of the pandemic. But hospitalization counts—which are still being reported—have risen in recent weeks.
“We can’t just forget about COVID-19 yet,” says Dr. Camins.
On Monday, September 11, the U.S. Food and Drug Administration (FDA) cleared updated COVID-19 vaccines for use that are formulated to more closely target currently circulating variants. The FDA approved the Pfizer and Moderna vaccines—known as “messenger RNA” or “mRNA” vaccines for the type of technology they use—for people 12 and over. It granted emergency use authorization to the same vaccines for people six months to 11 years old.
On Tuesday, September 12, a panel of the Centers for Disease Control and Prevention (CDC) voted to recommend the updated vaccines for everyone six months and older. The CDC recommended that most people get one dose of the new vaccine, at least two months after their most recent vaccine dose. People who are immunocompromised, and parents of young children, should consult their doctor for recommended dosing.
Dr. Camins said the updated COVID-19 shots from Pfizer and Moderna are monovalent vaccines—meaning they are designed to target a single variant of SARS-CoV-2, the virus that causes COVID-19—but are expected to provide broad protection against the other currently dominant circulating variants of SARS-CoV-2 as well. He said patients should check with their primary care doctor’s office or local pharmacy to find out how and when they can get the new vaccines.
“Based on past developments, it could be within a matter of days for the shots to be available to the public once the recommendation is made,” says Dr. Camins.
The number of people hospitalized due to COVID-19 has been rising steadily in the city in August. Source: NYC Department of Health and Mental Hygiene
RSV
The respiratory syncytial virus commonly causes mild, cold-like symptoms in most healthy adults and goes away after a few days. However, for infants and older adults with pre-existing heart disease or lung disease, RSV can cause severe disease. This year, new vaccines are available for these vulnerable groups.
“RSV is ubiquitous,” says Dr. Duchon. “You can try to prevent it, but even then options are limited. While parents can practice good hand hygiene and stay away from other sick people, babies often have siblings who go to school or go to daycare.”
Most of the deaths or severe disease—typically lower-respiratory-tract disease—from RSV occur in infants ages 0 to 6 months, says Dr. Duchon.
In July, the FDA approved Beyfortus™ (nirsevimab-alip), marketed by Sanofi in the United States, for use in infants entering their first RSV season and up to 24 months of age for those in vulnerable groups. In August, the FDA approved Abrysvo™, from Pfizer, as a maternal vaccine to protect infants from birth through six months of age. Beyfortus is administered directly to infants after they are born, while Abrysvo is given to mothers at 32 weeks through 36 weeks of gestation.
ACIP has recommended that Beyfortus be given to all infants younger than 8 months born during—or entering—their first RSV season, typically fall through spring. For children 8 to 19 months who are at increased risk of severe RSV disease, such as those who are immunocompromised, a second dose is recommended.
Abrysvo has yet to receive ACIP recommendation, though news reports have stated that meeting could likely occur in September.
~1-3%
of children under 12 months of age in the U.S. are hospitalized each year due to RSV
~60,000-120,000 hospitalizations and ~6,000-10,000 deaths
among adults 65 years of age and older are due to RSV
Source: CDC
It is possible that the ACIP could recommend Abrysvo on top of Beyfortus. “We are hoping that the infant vaccine will help prevent severe disease, and that the maternal vaccine will add an additional layer of protection,” says Dr. Duchon. However, she notes that given how the clinical trials were set up, the expert panel will likely examine the data closely and deliberate on the messaging.
“This could be a shared decision-making situation between a mother and her doctor,” Dr. Duchon adds.
For older adults, the FDA approved Arexvy™ as a vaccine for people ages 60 and older, in May. “Particularly for people with heart or lung disease, RSV can exacerbate their conditions,” says Dr. Camins.
Older people in that vulnerable group should speak with their health provider on whether they should take the vaccine, especially as RSV season approaches, says Dr. Camins.
Influenza
The influenza virus season from fall 2022 to spring 2023 was marked by an early peak in November and December last year, according to the CDC. When the 2023-2024 flu season will peak is hard to pinpoint, but the CDC issued a recommendation in August for people to receive their flu shots in September or October.
“We are starting to see some influenza A cases here in our health system, which has a connection to how influenza A and B trends might play out through fall and winter,” says Dr. Camins. It is not a prediction of an early or bad flu season by any means, but he recommends that unless contraindicated, everyone older than six months of age take the flu shot.
The annual flu vaccine has been updated with a new formula, as is common, to target strains most likely to circulate this season. Anyone six months and older is recommended to receive it, according to the CDC.
Last year, the City Department of Health and Mental Hygiene encouraged people to receive both their flu shots and COVID-19 shots together, where possible. Officials have been urging a similar message for New Yorkers to be caught up on their routine vaccinations.
“Even if you’re not at high risk for complications from the flu, getting the vaccine may prevent you from getting sick, or even if you do get sick, your symptoms will be milder if you take the shot than if you didn’t,” says Dr. Camins. “Everyone should be getting the flu vaccine.”
Updated on Jan 9, 2024 | COVID-19, Featured
If you are noticing that people you know are getting COVID-19, you are probably not alone. In fact, the number of cases in the New York area has risen recently. But this type of periodic fluctuation has been expected and is generally not a reason for concern, experts say.
“There is no reason to dramatically change our behavior when it comes to basic safety precautions and protecting vulnerable people,” says Bernard Camins, MD, MSc, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai and the Medical Director for Infection Prevention for the Mount Sinai Health System.
Among the possible reasons for an uptick in hospitalizations could be the recent extreme hot weather that pushed people to stay indoors, or that people are gathering more because of summer travel.
The New York City Department of Health and Mental Hygiene reports hospitalizations in New York surged in July, but the number is still a small fraction of what it was in January of 2022 during the last big surge. There have been virtually no deaths for several months.
You may have heard about a new variant of COVID-19, known as Eris. Mutations or changes in the virus are normal and expected, and experts track them closely. In this case, there does not seem to be anything significantly different about this new subvariant. It causes the same symptoms, and people do not get sicker when infected by it.
Most important, Dr. Camins’ recommendations remain unchanged:
- Those at risk of complications from COVID-19 may want to wear a protective mask (N95 or KN95) in crowded areas.
- Always wash your hands when you get home or arrive at work.
- Individuals at high-risk should talk with their health care provider and have a plan for how to get antiviral medications if they become infected, as these prescription medications must be taken within the first five days of symptom onset. Those at high-risk include older adults, those with chronic medical conditions, such as diabetes, and those with reduced ability to fight infections, such as those being treated for some cancers.
- If you feel stick, stay at home.
Bernard Camins, MD, MSc
Here are four key takeaways from Dr. Camins and heath care experts about how we are all living with COVID-19 now.
It’s endemic
COVID-19 is now considered endemic in our society, which means it is a constant presence, and we should expect it to come and go, such as the common cold or the seasonal flu. The U.S. Centers for Disease Control and Prevention (CDC) officially declared the end of the pandemic in May, 2023. A pandemic refers to a disease that spreads rapidly and beyond control around the world.
Be sure to check the right number
Since the official end of the pandemic, health authorities are no longer reporting the daily cases of COVID-19. One reason is those figures are no longer an accurate measure because so many people are testing at home if they suspect they may be infected. Hospitalizations are still being reported. Ongoing measurements of the level of SARS-CoV-2 virus in wastewater may be a better measure of how widespread the virus is in the population, and that has shown a slight uptick in recent weeks, according to Dr. Camins.
New vaccines are on the way
The U.S. Food and Drug Administration (FDA) is working with vaccine manufacturers to prepare a new COVID-19 vaccine booster for the fall that will target the latest variants. Any new vaccine must be approved for use by the FDA and then recommended by the CDC and state health authorities before you can get it.
Don’t forget your flu shot
Now is the time to begin thinking about getting your flu shot. September and October are the best times to get the flu shot, according to the CDC. In addition, you may want to talk with your provider about the a vaccine against Respiratory Syncytial Virus (RSV), a common respiratory virus that usually causes mild, cold-like symptoms but can be serous for infants and older adults. The CDC is recommending the vaccine for older adults, adults with chronic heart or lung disease, with weakened immune systems, or those living in nursing homes or long-term care facilities. A CDC advisory committee has recommended the vaccine for infants under eight months.
Updated on Mar 17, 2023 | COVID Response, COVID-19, Featured, Your Health
It has been three years since COVID-19 was declared a pandemic on March 11, 2020, by the World Health Organization. With New York City as an early epicenter, residents were hit hard. But from that experience, health care providers and researchers across the city found the opportunity to learn more about the virus and how to prepare for future pandemics.
Today, the city’s level of community transmission of COVID-19 is considered low, and the percentage of people who have completed their primary series of COVID-19 vaccinations is relatively high, according to the Centers for Disease Control and Prevention (CDC). Similarly, hospitalization and mortality rates from COVID-19 remained low in recent months, compared to the period between 2020 and 2022.
Bernard Camins, MD
These factors mean that New Yorkers can probably afford to relax their vigilance compared to previous years, notes Bernard Camins, MD, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai and Medical Director for Infection Prevention at the Mount Sinai Health System.
“We have come a long way. However, we still need to monitor how COVID-19 is affecting those who are at high risk of complications.”
Bernard Camins, MD
Who should remain vigilant?
Vulnerable groups include those who are immunocompromised, and those aged 50 and older, even if they’ve been vaccinated for COVID-19. People with certain underlying medical conditions, such as cancer; chronic kidney, lung, or liver disease; dementia; diabetes; heart conditions, or obesity are also considered at heightened risk.
For younger or healthy individuals, having COVID-19 these days might involve cold-like or mild symptoms, says Judith Aberg, MD, Chief of Infectious Diseases for the Mount Sinai Health System and Dr. George Baehr Professor of Clinical Medicine at the Icahn Mount Sinai. But vulnerable populations are at risk for developing severe disease, she adds. This includes hospitalization, needing intensive care, requiring a ventilator to breathe, or even death.
For at-risk groups, masking is recommended, as is avoiding large indoor gatherings. People planning to be organ donors should also remain vigilant for signs and symptoms of COVID-19, as an active infection could complicate one’s ability to donate, Dr. Aberg says.
“Also, people seem to have forgotten about hand hygiene; that is still important,” she notes.
What protection measures are available today?
With the federal Test to Treat initiative in place nationwide since 2022, symptomatic individuals who test positive for COVID-19 at testing sites can receive antiviral treatment, such as Paxlovid, on the spot.
“Taking Paxlovid provides that extra protection from developing complications, and the sooner it is taken, the better,” says Dr. Camins. Patients are recommended to receive antiviral treatment within five days of developing symptoms.
“One mistake people make with antivirals is that they wait to see if they feel better or worse before seeking treatment.”
Judith Aberg, MD
“If you’re a senior citizen, or have any of the underlying health conditions, when you test positive and have any symptoms, go seek treatment immediately. Do not wait,” says Dr. Aberg.
All individuals, and especially vulnerable populations, should stay up to date with COVID-19 vaccines, including the bivalent boosters, which are authorized for those ages 5 and older. “However, among people who were recommended to receive the bivalent booster, very few of them did,” Dr. Camins points out. “It seems many people have moved on regarding the pandemic before we really should.”
Judith Aberg, MD
According to the CDC, 17 percent of the U.S. population ages 5 and up have received the updated booster. In New York, that number is 18 percent.
Data have shown that the updated boosters either prevented infection or reduced the possibility of developing severe disease in people who received them. Another possible benefit of keeping up to date with vaccination is that it might prevent new variants from being as deadly as previous strains, Dr. Aberg says.
Will we need annual boosters?
Just as the bivalent boosters were updated to protect against current circulating variants and strains of SARS-CoV-2, the virus that causes COVID-19, researchers and officials are monitoring how the pathogen continues to evolve. Most of the scientific and medical community believe that the virus is headed in the direction of becoming endemic, or regularly occurring, Dr. Aberg says. “However, the jury is still out on whether annual updated boosters will be necessary,” she adds.
Neither the Food and Drug Administration nor the CDC has made any determinations on recommending annual COVID-19 shots, unlike what they have done with the flu. The data on COVID-19 collected over the recent winter could provide clarity on whether another shot might be needed this fall, says Dr. Aberg.
There are other seasonal coronaviruses and rhinoviruses that cause respiratory infections that do not require annual boosters. “It’s hard to predict whether the virus will take another turn to cause more morbidity or mortality. We’ll have to wait to see what the data shows us,” Dr. Aberg says.
What other things about COVID-19 should we be aware of?
The public health emergency declaration, which has been in place since 2020, will come to an end on Thursday, May 11, 2023. This might have implications regarding cost sharing or coverage regarding various COVID-19-related services, such as testing, treatment, or vaccinations. This might mean some services will no longer be free or will start requiring copays, depending on the insurance.
While the New York State Department of Health has not released any guidance on cost impacts, providers need to inform their patients and communities to follow up with their insurance companies and be aware of possible coverage changes, Dr. Aberg says.
“People need to be informed about potential costs before seeking COVID-19 care,” Dr. Aberg notes. “But on the other hand, we don’t want people to avoid seeking help because of cost.” If a patient experiences troubling symptoms, such as shortness of breath or fever, they should see a primary care doctor or go to the emergency room, she adds.
The medical and science community is also closer to understanding post-acute sequelae of COVID-19, or the condition colloquially known as “long COVID.”
Anyone who is infected with COVID-19 has a risk of going on to develop long COVID, in which individuals experience symptoms that persist beyond three months after the acute phase. An estimated 1 in 13 adults in the United States have long COVID, according to the CDC.
“We’re starting to zero in on specific biomarkers for people with long COVID,” says David Putrino, PhD, Director of Rehabilitation Innovation for the Mount Sinai Health System. These include platelet hyperactivation, microclots, immune dysfunction, and microbiome dysfunction.
“We are getting the science to a place where we may finally be able to identify this condition objectively.”
David Putrino, PhD
David Putrino, PhD
This has allowed providers to be better educated about the sorts of things that could cause long COVID symptoms to flare up, Dr. Putrino says. The availability of objective biomarkers also means the ability to start testing therapeutics to treat long COVID.
“A year ago, I would have thrown my hands in the air and said there were no good drug trials for long COVID,” Dr. Putrino says. “Now, I feel a little confident that we can start promising patients that these trials are on the horizon.”
“We’re getting close to getting therapeutics to prescribe. I’m hoping that will be a reality over the next two years or so,” Dr. Putrino says.
Updated on Mar 17, 2023 | COVID Response, COVID-19, Featured, Research
While COVID-19 community transmission, mortality, and hospitalization rates have come down across the country in recent months, the efforts to understand more about SARS-CoV-2, the virus responsible for COVID-19, continue at full speed. “The energy is still robust,” says Judith Aberg, MD, Chief of Infectious Diseases for the Mount Sinai Health System and Dr. George Baehr Professor of Clinical Medicine at the Icahn School of Medicine at Mount Sinai.
Judith Aberg, MD
Much research progress has been made since COVID-19 was declared a pandemic by the World Health Organization on March 11, 2020, but more work remains to be done.
“At all levels, from academic institutions to federal agencies, resources are still being poured into studying COVID-19 and this level of dedication is unlikely to go away anytime soon.”
Judith Aberg, MD
“It is precisely because, as a community, we have put so much effort into studying COVID-19 that we were able to learn so much about the virus and come up with vaccines and therapeutics at an unprecedented pace,” says Miriam Merad, MD, PhD, Director of the Marc and Jennifer Lipschultz Precision Immunology Institute, and Mount Sinai Professor in Cancer Immunology.
How has COVID-19 knowledge grown over the years?
A recent breakthrough was learning why COVID-19 affects older people more severely than children, says Dr. Merad. In many other respiratory diseases, such as influenza, typically both very young and very old people are most susceptible to complications.
“One of the biggest factors we’ve discovered is that age affects innate immune response,” she says. Older individuals are more likely to have a defective response in which their type I interferon activity is less likely to mount an antiviral or anti-inflammatory response, she adds.
Understanding the links of age to inflammatory response had also been a big piece in solving the COVID-19 puzzle, Dr. Merad says.
“It appears that SARS-CoV-2 might not be directly destroying organs. Rather, pathogenic-led inflammation might be doing so instead.”
Miriam Merad, MD, PhD
While SARS-CoV-2 is in the class of coronaviruses, very little was known about its specific pathophysiology, how it infects cells and induces injury, and how the host can control the virus. The scientific community has made inroads into these fields over the past year, especially in recent months, Dr. Merad notes.
Miriam Merad, MD, PhD
At the start of the pandemic, there were also no objective biomarkers to characterize the disease. Today, researchers have identified various measures, including platelet hyperactivations, microclots, and immune and microbiome dysfunction, as ways to analyze the impacts of COVID-19 on the body, especially for post-acute sequelae of COVID-19, the condition colloquially known “long COVID.”
“It’s really bleeding-edge,” says David Putrino, PhD, Director of Rehabilitation Innovation at the Mount Sinai Health System. “It has really coalesced over time, and has taken two years before impressive articles were coming out about meaningful biomarkers.”
How had COVID-19 research been challenging?
“It is really difficult to do research in the middle of a pandemic,” recalls Dr. Merad. With measures in place to keep staff safe from infection, as well as prevent lab leaks, it became challenging to develop animal models. Additionally, given that COVID-19 was a new disease, there were few good models to start with, she adds.
Barriers to knowledge, tools, or resources also made studying COVID-19 an uphill task. As the disease has symptoms that span multiple specialties, including neurology, immunology, pulmonology, cardiology, and more, an effective effort into studying the pathogen required broad capabilities.
David Putrino, PhD
“I’m a neuroscientist, focusing on electrophysiology of the brain, and had a set of tools I was comfortable using,” says Dr. Putrino. “But along came COVID-19 and suddenly I had to become an expert on immune physiology, on drawing blood, and running a wet lab.”
“Collaboration became necessary, especially with people outside our usual fields.”
David Putrino, PhD
“While I feel fortunate that I’m in a position from a funding and career standpoint that can support my needs for long COVID research, many others aren’t as fortunate to develop those skill sets,” Dr. Putrino says. The reality of many scientists needing to keep their labs running and applying for grants could mean it was easier to relegate COVID-19 research to someone else, he adds.
The nascent field of COVID-19 research, especially for long COVID, means the scientific community is still divided on various definitions. But with the pandemic dying down, researchers are able to communicate and collaborate more effectively across the country on standards and definitions when it comes to conducting research or collecting data, especially as scientific conferences return in full force, Dr. Merad says.
What are some things we still don’t know about COVID-19?
On the clinical side, it is not clear for hospitalized patients what are the best immune modulating therapies or strategies. “When should we start combination immune modulating therapies? Are antivirals effective in patients on high flow oxygen if they still are shedding virus?” says Dr. Aberg. “We are still trying to optimize modalities.”
New treatments for COVID-19, including antiviral drugs such as Paxlovid, are now available to help reduce the likeliness of developing severe disease. But some shortfalls remain.
“For example, Paxlovid has significant drug-to-drug interactions and not everyone can take that,” notes Dr. Aberg. “We’re still learning how to be able to manage those who are immunocompromised and are experiencing persistent viral shedding.”
Some of the monoclonal antibody treatments that had been developed for COVID-19 and had shown efficacy earlier in the pandemic have since become less effective against current circulating variants. “We need to develop tools for rapid sequencing of virus to detect which variant is causing disease while simultaneously having available active antibody therapies. We hope that future anti-SARS-CoV-2 monoclonal antibodies will be effective to treat and prevent COVID-19, especially for those who are immunocompromised,” Dr. Aberg says.
In basic science, many questions about viral pathophysiology remain unanswered, especially with regards to how it affects coagulation, thrombosis, and inflammation, says Dr. Merad. Even with the success of COVID-19 vaccines at reducing infection incidence and severity, people still can still be infected, and it is not clear why that is so, she adds.
What is the current state of COVID-19 research and where is it headed?
Clinicians are looking at whether they can combine different treatment modalities, especially for immunocompromised patients, says Dr. Aberg.
The National Institutes of Health is still conducting its efforts through the networks the agency has formed during the pandemic, and is conducting multicenter clinical trials, Dr. Aberg points out. It has preserved its expedited pipeline for testing novel therapeutics, including the use of “adaptive platform studies,” where new investigative agents could use an adapted template without the need for developing a new protocol from scratch.
Long COVID clinical trials are coming down the pipeline, says Dr. Putrino. A trial to test the use of Paxlovid for treating long COVID has received an Institutional Review Board approval from the Food and Drug Administration, making it one of the first of its kind for a targeted treatment of the condition, he notes.
The discovery of objective biomarkers will also pave the way for new drugs to be developed for long COVID, or for existing treatments to be explored, says Dr. Putrino.
These biomarkers could also be leveraged for uses beyond COVID-19. “The pandemic made us realize how we have few assays to measure our immune fitness to tell us whether someone can be susceptible to disease,” says Dr. Merad. Immune biomarkers could be used to develop assays to measure whether an individual could mount a good immune response, perhaps to vaccination, or just in general. “Can we build novel tools to measure our immune fitness, in the same way we can measure our blood sugar?” she questions.
It is undeniable that clinicians and researchers are committed to COVID-19 research, says Dr. Merad. “That’s what we’re fighting for,” she says. “We’re talking to everyone—industry partners, government entities—on the need for continued effort, and everyone is on board.”
Here are Some COVID-19 Research Milestones at Mount Sinai
2022
- Dec 8: Mount Sinai researchers published one of the first studies about changes in blood gene expression during COVID-19 being linked to long COVID
- Aug 9: Mount Sinai launched CastleVax, a clinical-stage vaccine research and development company, whose capabilities can be leveraged to tackle SARS-CoV-2
- June 28: Mount Sinai-led team showed immune particles derived from the blood of a llama could provide strong protection against every COVID-19 variant
- June 14: Mount Sinai researchers have developed a rapid blood assay that measures the magnitude and duration of someone’s immunity to SARS-CoV-2
- Mar 31: Faculty from the Icahn School of Medicine at Mount Sinai play key roles in the SAVE program, established by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH)
- Mar 21: Clinical investigators at the Icahn Mount Sinai launched a Phase 1, open-label, placebo-controlled study to evaluate the safety and immunogenicity of an egg-based COVID-19 vaccine in healthy, vaccinated adults who have never been infected with COVID-19
2021
- Nov 29: Icahn Mount Sinai served as a hub site for two cohort studies as part of nationwide health consortium study by NIH on the long-term effects of SARS-CoV-2
- May 25: Mount Sinai and the Pershing Square Foundation expanded a saliva-based COVID-19 testing program
- April 5: Mount Sinai launched the Mount Sinai COVID-19 PCR Saliva Testing program for businesses and leisure activities in New York
- Jan 27: Mount Sinai researchers demonstrated using a machine learning technique called “federated learning” to examine electronic health records to better predict how COVID-19 patients will progress
- Jan 27: Scientists at University of California, San Francisco, and the Department of Microbiology at Icahn Mount Sinai reported data showing the promise and potential of Aplidin® (plitidepsin), a drug approved by the Australian Regulatory Agency for the treatment of multiple myeloma, against SARS-CoV-2
2020
- Dec 29: Emergent BioSolutions and Mount Sinai initiated a clinical program to evaluate COVID-19 Human Hyperimmune Globulin product candidate in the first of two Phase 1 studies for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2
- Sept 17: The Clinical Laboratories of The Mount Sinai Hospital has received emergency use authorization from the New York State Department of Health for quantitative use of Mount Sinai’s COVID-19 antibody test
- June 17: Mount Sinai submitted a request to the U.S. Food and Drug Administration (FDA) for issuance of an emergency use authorization for quantitative use of its serologic test
- May 14: Mount Sinai established the Institute for Health Equity Research to understand the effects of health issues including COVID-19
- April 15: Mount Sinai Laboratory, Center for Clinical Laboratories received emergency use authorization from the UFDA for an antibody test
- April 3: Mount Sinai developed a new remote monitoring platform to help health care providers care for COVID-19 patients who are recovering at home
- April 1: Scientists, physicians, and engineers at Mount Sinai launched STOP COVID NYC, a web-based app to capture the symptoms and spread of COVID-19 in New York City
Mar 7, 2023 | Cardiology, COVID-19, Featured, Research
The FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.
An international trial led by Mount Sinai found that high-dose anticoagulation can reduce deaths by 30 percent and intubations by 25 percent in hospitalized COVID-19 patients who are not critically ill, when compared to the standard treatment, which is low-dose anticoagulation. The innovative FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.
The study results were announced Monday, March 6, in a late-breaking clinical trial presentation at the scientific sessions of the American College of Cardiology Together With World Congress of Cardiology (ACC.23/WCC) in New Orleans and simultaneously published in the Journal of the American College of Cardiology.
“What we learned from this trial is that many patients hospitalized with COVID-19 with pulmonary involvement, but not yet in the intensive care unit (ICU), will benefit from high-dose subcutaneous enoxaparin or oral apixaban to inhibit thrombosis and the progression of the disease,” Dr. Fuster says. “This is the first study to show that high-dose anticoagulation may improve survival in this patient population—a major finding since COVID-19 deaths are still prevalent.”
Clinical Insights, Early in the Pandemic
This work was prompted by the discovery early in the pandemic that many patients hospitalized with COVID-19 developed high levels of life-threatening blood clots. In March 2020, during the early days of the pandemic, Dr. Fuster observed patients with blood clots in their legs who had been admitted with COVID-19. After hearing from colleagues abroad of other cases of small, pervasive, and unusual clotting that had triggered myocardial infarctions, strokes, and pulmonary embolisms, he initiated decisive action.
“We became one of the first medical centers in the world to treat all COVID-19 patients with anticoagulant medications,” says Dr. Fuster, a pioneer in the study of atherothrombotic disease. “It was a decision that we believe saved many lives.”
This early protocol led to groundbreaking research and insights by Mount Sinai into the role of anticoagulation in the management of COVID-19-infected patients. Mount Sinai research showed that treatment with prophylactic (low-dose) anticoagulation was associated with improved outcomes both in and out of the intensive care unit among hospitalized COVID-19 patients. Researchers further observed that therapeutic (high-dose) anticoagulation might lead to better results. Then, they designed the FREEDOM COVID Anticoagulation Strategy Randomized Trial to look further into the most effective regimen and dosage for improving outcomes of hospitalized COVID-19 patients who are not critically ill.
Researchers enrolled 3,398 hospitalized adult patients with confirmed COVID-19 (median age 53) from 76 urban and rural hospitals across 10 countries—including hospitals within the Mount Sinai Health System—between August 26, 2020, and September 19, 2022. Patients were not in the ICU or intubated, and about half of them had signs of COVID-19 impacting their lungs with acute respiratory distress syndrome (ARDS). Patients were randomized to receive doses of three different types of anticoagulants within 24 to 48 hours of being admitted to the hospital and followed for 30 days. Equal numbers of patients were treated with one of three different drug regimens: low-dose injections of enoxaparin, high-dose injections of enoxaparin, and high-dose, oral doses of apixaban. They compared the combined therapeutic groups to the prophylactic group.
Informing Future Care
The primary endpoint was a combination of death, requirement for ICU care, systemic thromboembolism (blood clots traveling through the arteries), or ischemic stroke at 30 days. This endpoint was not significantly reduced among the groups. However, 30-day mortality was lower for those treated with high-dose anticoagulation compared with those on the low-dose regimen. Seven percent of patients treated with the low-dose anticoagulation died within 30 days, compared with 4.9 percent of patients treated with high-dose anticoagulation—an overall reduction of 30 percent. The need for intubations was also reduced in the high-dose group: 6.4 percent of patients on the high-dose regimen were intubated within 30 days compared with 8.4 percent in the low-dose group—a 25 percent reduction. The study showed high-dose anticoagulation to be especially beneficial for patients with ARDS, a condition where COVID-19 damages the lungs. Among patients with ARDS at the time of hospital admission, 12.3 percent in the low-dose anticoagulation group died within 30 days, compared with 7.9 in the high-dose group.
All groups had low bleeding rates, and there were no differences between the two therapeutic blood thinners for safety and efficacy.
“This is an important study for patients with COVID-19 who are sick enough to require hospitalization but not so ill as to require ICU management. In this group of patients with radiologic evidence of ARDS, therapeutic dose anticoagulation prevents disease progression, especially the need for intubation, and saves lives,” says co-Principal Investigator Gregg W. Stone, MD, Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai. “This is especially important as COVID-19 is not going away. Even in the United States, the current number of daily deaths, although much lower than at the peak of the pandemic, is twice that compared with just one year ago. And in other countries COVID-19 is raging”
The FREEDOM trial was coordinated by the Mount Sinai Heart Health System. Dr. Fuster raised all funding for the trial.
