Primary Source Records · Source Documents
Combat COVID (combatcovid.hhs.gov)
The public-facing HHS site that explained monoclonal antibodies, antivirals, convalescent plasma and clinical trials to ordinary people deciding what to do, in English and Spanish. It is the government’s own word on treatments at the time it was giving it. The host no longer resolves. 49 pages are held here, recovered from the Internet Archive.
- Period
- 2021
- Region
- United States
- Language
- English
- Rights
- Public domain. A work of the United States Government is not subject to copyright under 17 U.S.C. § 105, so it is held in full with no exception claimed and none needed. Published by U.S. Department of Health and Human Services at combatcovid.hhs.gov, where the host no longer resolves in DNS as last checked on 2026-09-22.
- Source
- https://combatcovid.hhs.gov/
Full text
COMBAT COVID (COMBATCOVID.HHS.GOV) U.S. Department of Health and Human Services
Captured from the Internet Archive on 2026-09-22. combatcovid.hhs.gov no longer resolves in DNS. This file holds 49 pages, the most substantial the Archive has for that host. It is a capture of a site, not a complete mirror of it: pages the Archive never visited are not here, and neither are images, downloads or anything the site generated for a logged-in visitor. Each page is headed with its title, its address and its capture date.
COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov combatcovid.hhs.gov/hcp/resources?twclid=11417978803008114688 — captured 2021-07-22
BREAKING NEWS:
The U.S. government is pausing the distribution of monoclonal antibodies bamlanivimab and etesevimab in high-risk COVID-19 outpatients. The monoclonal antibodies have shown to not work well against other types of the COVID-19 virus. Healthcare providers can learn more here . Learn if you or a loved one are at a higher risk for COVID-19 .
Early intervention with monoclonal antibody treatment may reduce the risk of severe illness and hospitalization for people with COVID-19 who are at high risk of developing more serious illness. Here are resources that can help you ensure rapid access to monoclonal antibody treatment for your high-risk COVID-19 patients.
The following documents provide promising practices and recommendations from provider organizations and states that have had success in increasing the utilization of COVID-19 monoclonal antibody treatments. These findings provide inspiration and information to those working to build treatment awareness and demand and can supplement individual plans and provide context to playbooks and planning discussions with leadership.
ACTIV CLINICAL TRIALS FINDER | combatCOVID.hhs.gov combatcovid.hhs.gov/ACTIVClinicalTrialsFinder — captured 2021-11-25
ACTIV CLINICAL TRIALS FINDER
Find possible COVID-19 clinical trials for your patient.
Answer key questions to learn about options for your patients to join a clinical trial that is evaluating new treatments for COVID-19. Select the options that best match your patient’s condition to narrow down the available trials (found below the finder ACTIV Clinical Trials Finder). Note: specific inclusion criteria may not reflect the most current study protocol.
Click on the "Find" button to see the updated list of possible clinical trials for your patient.
*Having a weakened immune system (also known as being "immunocompromised") means that a person’s white bloods cells are less effective at fighting disease. Many illnesses can cause a weakened immune system, including chronic (long-term) conditions like diabetes and cancer; infections, like HIV; and some autoimmune diseases like lupus or rheumatoid arthritis. Sometimes, medications a person is taking may cause the immune system to weaken. These may include medications related to chemotherapy, systemic steroids, methotrexate, and others.
**Symptoms may include one or more of the following: fever cough fatigue diarrhea sore throat body pains and aches headache, chills nausea/vomiting difficulty breathing/shortness of breath/dyspnea new loss of sense of taste or smell nasal symptoms/congestion/discharge
ACTIV CLINICAL TRIAL OPTIONS FOR YOUR PATIENT
Your patient may qualify for the clinical trial(s) listed below.
The eligibility criteria is time-sensitive.
Please encourage your patient to contact the trial(s) as soon as possible to learn more about how to participate. Each trial has its own direct contact information.
OTAC: OUTPATIENT TREATMENT WITH ANTI-CORONAVIRUS IMMUNOGLOBULIN (IMMUNOCOMPROMISE)
What treatment is being tested in this trial? COVID-19 disease is caused by infection with the SARS-CoV-2 virus. Anti-SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) is made by combining and concentrating antibodies from different healthy people who have recovered from COVID-19. The anti-SARS-CoV-2 antibodies bind to the virus and keep it from entering into cells. It is also different from “convalescent plasma” from a single person in that hIVIG consistently provides a high level of antibodies. In the lab it has been shown to work better against “variant” (i.e., “mutated” or changed) forms of the SARS-CoV-2 virus than single or combination antibody treatments. Variant forms of the virus have become widespread in different parts of the world.
What is the type of clinical trial being conducted? Randomized, double-blind, placebo-controlled trial. Participants will have a 50-50 chance (like tossing a coin) of being assigned to the “active” study drug, hIVIG, or placebo (salt water with no study drug).
About this trial: People early on in their infection who test positive for COVID-19 and have a higher risk of getting very sick will take part in this study. The study team hopes to find out if giving anti-SARS-CoV-2 hIVIG to people early in their infection with COVID-19, before the body has had a chance to make its own antibodies, can help prevent bad effects from COVID-19 and enable them to stay out of the hospital. If you join this study you will receive either the study drug, hIVIG, or placebo given through a vein in the arm as a single dose. You will also get the usual treatment and care for COVID-19 according to local guidelines. The study lasts 28 days with some of the scheduled study visits taking place over the phone.
ACTIV-4 HOST TISSUE: NOVEL EXPERIMENTAL COVID THERAPIES AFFECTING HOST RESPONSE (NECTAR)
What drugs are being tested in this trial? Several different new drugs are being studied to help people in the hospital with COVID-19. Each drug is different and may be given in a different way. This can include by IV, mouth, or injection.
What is the type of clinical trial being conducted? This is a randomized, double-blind, placebo-controlled trial.
About this trial: You may be able to join the NECTAR study if you have tested positive for COVID-19 and are in the hospital. If you join the study, you will either receive a study drug or something that looks like the study drug but has no medicine in it called a placebo.
The chance of receiving either a study drug or the placebo depends on the number of study drugs available when you join the study. You will not know if you are receiving the study drug or the placebo. Both groups are important to the study to help find out if getting the new drugs are better than not getting them.
You will be in this study for 90 days. You do not need to be in the hospital this entire time. You will receive the study treatment for up to 14 days, depending on which drug you are assigned.
OTAC: OUTPATIENT TREATMENT WITH ANTI-CORONAVIRUS IMMUNOGLOBULIN
What treatment is being tested in this trial? COVID-19 disease is caused by infection with the SARS-CoV-2 virus. Anti-SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) is made by combining and concentrating antibodies from different healthy people who have recovered from COVID-19. The anti-SARS-CoV-2 antibodies bind to the virus and keep it from entering into cells. It is also different from “convalescent plasma” from a single person in that hIVIG consistently provides a high level of antibodies. In the lab it has been shown to work better against “variant” (i.e., “mutated” or changed) forms of the SARS-CoV-2 virus than single or combination antibody treatments. Variant forms of the virus have become widespread in different parts of the world.
What is the type of clinical trial being conducted? Randomized, double-blind, placebo-controlled trial. Participants will have a 50-50 chance (like tossing a coin) of being assigned to the “active” study drug, hIVIG, or placebo (salt water with no study drug).
About this trial: People early on in their infection who test positive for COVID-19 and have a higher risk of getting very sick will take part in this study. The study team hopes to find out if giving anti-SARS-CoV-2 hIVIG to people early in their infection with COVID-19, before the body has had a chance to make its own antibodies, can help prevent bad effects from COVID-19 and enable them to stay out of the hospital. If you join this study you will receive either the study drug, hIVIG, or placebo given through a vein in the arm as a single dose. You will also get the usual treatment and care for COVID-19 according to local guidelines. The study lasts 28 days with some of the scheduled study visits taking place over the phone.
ACTIV-3B: THERAPEUTICS FOR SEVERELY ILL INPATIENTS WITH COVID-19 (TESICO): DETERMINING WHICH TREATMENTS HELP HOSPITALIZED ADULTS WITH ACUTE RESPIRATORY DISTRESS DUE TO COVID-19 GET BETTER
What drugs are being tested in this trial? Aviptadil and remdesivir (additional drugs may be added later).
What is the type of clinical trial being conducted? Randomized, double-blind, placebo-controlled trial.
About this trial: This trial is enrolling adult patients being treated in the hospital for COVID-19 who are experiencing acute respiratory failure, a condition in which patients are critically ill and have difficulty breathing. This study will assess if aviptadil and remdesivir together or alone are safe and help patients recover more quickly from COVID-19.
Aviptadil is a man-made version of a hormone (Vasoactive Intestinal Peptide or VIP) found naturally in the body, which may decrease COVID-19 virus levels, inflammation, and help protect the lungs. Remdesivir (Veklury®) is an antiviral drug that may decrease COVID-19 virus levels and lung injury. It is approved as a treatment for people in the hospital with COVID-19 but it is not known if it will help people with serious COVID-19 illness who need very high levels of oxygen or a ventilator. Both study drugs are given by intravenous (IV) infusion.
In general, patients will have a 3 in 4 chance of receiving one or both of the study drugs. (Depending on the specifics of their medical situation, some patients may only be randomized to one drug or its placebo, in which case they would have a 1 in 2 chance of receiving the study drug.) Other study drugs may be added to the trial in the future. Drug treatments that show little effectiveness will be dropped from the trial and other therapies can be added.
ACTIV-3 THERAPEUTICS FOR INPATIENTS WITH COVID-19 (TICO): A MULTICENTER, ADAPTIVE, RANDOMIZED, BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR HOSPITALIZED PATIENTS WITH COVID-19
The number of study drugs available will determine the chance that a study participant receives a study drug rather than placebo. If a participant is able to receive either of the study drugs, their chance of getting a study drug is 67 percent (2 in 3).
What drugs are being tested in this trial?
- AZD7442 monoclonal antibodies. Monoclonal antibodies are laboratory-made versions of proteins naturally produced by the body’s immune system to fight infections. AZD7442 has two monoclonal antibodies that were identified from people who recovered from COVID-19. Each of these monoclonal antibodies attaches to a different part of SARS-CoV-2 to try to stop it from multiplying in the body and help people recover from COVID-19.
- MP0420 DARPin. A DARPin is a protein that is made in a laboratory. MP0420 attaches to three different parts of SARS-CoV-2 to try to stop it from multiplying in the body and help people recover from COVID-19.
- Additional drugs may be added later.
What type of clinical trial is being conducted? A randomized, double-blind, placebo-controlled, adaptive platform trial.
Randomized means that whether trial participants get one of the study drugs or the placebo is decided by chance – like flipping a coin. Placebo-controlled means that some participants will receive a saltwater solution that has no drug in it. Trial participants will always have a 50 percent (50:50) chance or greater of getting a study drug. Double-blind means that neither the participant nor the research team will know if a participant is getting a study drug or the placebo. Adaptive platform means the trial has study drugs entering and leaving based on specific study requirements. This allows quick and careful assessments of study drugs to identify those that are safe and effective in treating people in the hospital with COVID-19.
About this trial: ACTIV-3/TICO is enrolling adults being treated in the hospital for COVID-19 and will examine how well study drugs compare with placebo in helping them to recover. It will determine if the study treatments are safe to use and help people go home from the hospital more quickly and stay home. Everyone in this study will also receive study-provided remdesivir (Veklury ® ), the only FDA-licensed treatment for patients in the hospital. Remdesivir is an antiviral drug that may decrease levels of the virus that causes COVID-19 (SARS-CoV-2) in the body. Another treatment often used for patients in the hospital with COVID-19 is dexamethasone, a steroid that helps people with COVID-19 who require oxygen or other respiratory support.
ACTIV-2: DETERMINING WHICH INVESTIGATIONAL MEDICATIONS CAN HELP ADULTS WITH COVID-19 GET BETTER
What drugs are being tested in this trial? Multiple different medicines against COVID-19.
What is the type of clinical trial being conducted? Randomized, double-blind, placebo-controlled trial.
About this trial: The ACTIV-2 study is testing different investigational medicines to see if they are safe and can help adults with COVID-19 get better. The investigational medicines that researchers believe are most likely to help people with COVID-19 will be tested in this study. One type of investigational medicine you might receive in the study is a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the laboratory and help your body attack invaders, such as viruses, to keep them from entering your cells. Promising medicines other than monoclonal antibodies are also being tested in this study. If you decide to join you would be given information about the medicines currently being tested.
ACTIV-5: BIG EFFECTS TRIAL (BET)
What investigational drugs are being tested in this study? Several investigational drugs.
What type of clinical trial is being conducted? Randomized, double-blind, placebo-controlled trials.
About this trial: ACTIV-5 compares different types of drugs (immune modulators, antivirals, and others) against a common placebo patients in the hospital with COVID-19. It is enrolling a smaller number of participants to detect which treatments have a big effect on patient outcomes and should be moved quickly into larger studies. Drug treatments that show little effectiveness will be dropped from the trial to allow other therapies to be added.
ACTIV-4: (ACTIV-4C) DETERMINING HOW EFFECTIVE BLOOD THINNERS ARE IN REDUCING BLOOD CLOTS IN ADULTS DIAGNOSED WITH COVID-19
What treatments are being tested in this trial? Blood thinners.
What is the type of clinical trial being conducted? Randomized, open-label study.
About this trial: ACTIV-4 is assessing the safety and effectiveness of different kinds of blood thinners to treat adults diagnosed with COVID-19. Many patients who died from COVID-19 had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting problem has caused multiple health complications from organ damage to heart attack, stroke, and blockage in arteries in the lungs. ACTIV-4 trials aim to prevent and treat life-threatening COVID-19-associated blood clotting.
ACTIV-4C for patients who are recovering after hospital discharge: This clinical trial is assessing the effectiveness and safety of blood thinning drugs in reducing complications from blood clots such as heart attack, stroke, blood clots in major veins and arteries, blood clots in veins deep in the body and/or in arteries in the lungs, and death in patients who have been discharged from the hospital and are recovering. Participants will be assigned to take either a low dose of the blood thinner apixaban (Eliquis®) or placebo.
ACTIV-4: (ACTIV-4A) DETERMINING HOW EFFECTIVE BLOOD THINNERS ARE IN REDUCING BLOOD CLOTS IN ADULTS DIAGNOSED WITH COVID-19
What treatments are being tested in this trial? Antithrombotics (blood thinners).
What is the type of clinical trial being conducted? Randomized, open-label study.
About this trial: ACTIV-4 is assessing the safety and effectiveness of different kinds of blood thinners to treat adults diagnosed with COVID-19. Many patients who died from COVID-19 had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting problem has caused multiple health complications from organ damage to heart attack, stroke, and blockage in arteries in the lungs. ACTIV-4 trials aim to prevent and treat life-threatening COVID-19-associated blood clotting.
ACTIV-4A for patients in the hospital: This clinical trial for patients who are in the hospital with COVID-19 is assessing the safety and effectiveness of different doses and types of heparin, a blood thinner, to prevent or reduce the formation of blood clots. This treatment may be given with remdesivir (Veklury®), an FDA-approved antiviral for patients in the hospital that reduces the ability of viruses to multiply in the body.
ACTIV-1
What treatments are being tested in this trial? Immune modulators and remdesivir.
What is the type of clinical trial being conducted? Randomized, double-blind, placebo-controlled trial.
About this trial: This trial is enrolling adult patients who are already in the hospital with moderate to serious COVID-19 disease. The trial is testing promising drugs that modulate, or adjust, the immune system to help reduce the harmful effects that can occur when the immune response to a COVID-19 infection is too strong. These drugs are called immune modulators. In this trial doctors assess the safety and effectiveness of three immune modulators taken with an antiviral called remdesivir (Veklury®), which has already been approved by the FDA for use in patients in the hospital. Antivirals like remdesivir reduce the ability of viruses to multiply in the body. Doctors will study the different treatments to see how well they reduce the severity of the illness and speed recovery.
ACTIV-6: DETERMINING WHICH REPURPOSED MEDICINES CAN HELP ADULTS WITH COVID-19 GET BETTER
What drugs are being tested in this trial? Multiple different FDA-approved medicines repurposed against COVID-19.
What is the type of clinical trial being conducted? Randomized (like a flip of a coin), double-blind (you and your doctor will not know which medicine you’re taking), placebo-controlled trial (a treatment that has none of the active drug in it).
About this trial: The ACTIV-6 study is testing medicines that are currently used for treating health conditions other than COVID-19 to see if these medicines can be used for treating COVID-19. The main goal is to find out if these medicines can help people with mild to moderate COVID-19 feel better faster and stay out of the hospital. Before you decide if you want to join the study you will know what medicines are being tested. If you join you will receive the usual treatment for your condition plus any study treatment as part of the ACTIV-6 trial. This study is designed to be done remotely so it can fit into your life easily. The ACTIV-6 study is currently for people who are at least 30 years old, have been diagnosed with COVID-19 and have symptoms, and who are not currently in the hospital.
COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov combatcovid.hhs.gov/hcp/resources?twclid=11417106058347155457 — captured 2021-07-19
BREAKING NEWS:
The U.S. government is pausing the distribution of monoclonal antibodies bamlanivimab and etesevimab in high-risk COVID-19 outpatients. The monoclonal antibodies have shown to not work well against other types of the COVID-19 virus. Healthcare providers can learn more here . Learn if you or a loved one are at a higher risk for COVID-19 .
Early intervention with monoclonal antibody treatment may reduce the risk of severe illness and hospitalization for people with COVID-19 who are at high risk of developing more serious illness. Here are resources that can help you ensure rapid access to monoclonal antibody treatment for your high-risk COVID-19 patients.
This document includes promising practices and recommendations from Maryland’s success in increasing the utilization of COVID-19 monoclonal antibody treatments. These findings provide inspiration and information to those working to build treatment awareness and demand and can supplement individual plans and provide context to playbooks and planning discussions with leadership.
====================================================================== Monoclonal Antibodies for High-Risk COVID-19 Positive Patients | combatCOVID.hhs.gov combatcovid.hhs.gov/i-have-covid-19-now/monoclonal-antibodies-high-risk-covid-19-positive-patients?gclid=Cj0KCQiA4L2BBhCvARIsAO0SBdZMrugJ5Fp6oP8mGp9JPdVWWDCa5sW2iYUg8UvR04J1ZEFF4CB1oOAaAoyBEALw_wcB — captured 2021-04-12 ======================================================================
If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.
Some early evidence suggests that mAb treatment can reduce the amount of the SARS-CoV-2 virus (the virus that causes COVID-19) in a person's system. This amount is known as viral load. Having a lower viral load means you may have milder symptoms thereby decreasing the likelihood of you being hospitalized.
mAb treatment may help people who:
- Have a positive COVID-19 test, and had symptoms for 10 days or less, and
- Are at high risk of getting more serious symptoms.
Visit the page “ How Do I Know If I’m High Risk, and What Do I Do Next? ” to learn more.
This page describes what mAbs are, how they can prevent mild to moderate symptoms from getting worse, and what to expect if you get mAb treatment.
FIND INFUSION LOCATIONS
Antibody drug cuts COVID-19 death risk by 70 percent
Regeneron and Roche's antibody cocktail shown helping in COVID-19 cases
Biden Administration to Invest $150 Million to Expand Access to COVID-19 Treatments in Underserved Communities
LOCAL NEWS
COVID-19 antibody infusions are saving lives in Evansville, Deaconess says
Palm Beach County doctors push for greater access to COVID-19 monoclonal antibody treatments
Carilion finding success with monoclonal antibody treatments in fight against COVID-19
Your body naturally makes antibodies to fight infection. However, your body may not have antibodies designed to recognize a novel (or new) virus like SARS-CoV-2, the virus that causes COVID-19. Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection—in this case, SARS-CoV-2—and are given to patients directly with an infusion. That’s why mAb treatment may help patients who are at high risk for severe symptoms or having to be hospitalized.
mAb treatment for COVID-19 is different from a COVID-19 vaccine. A vaccine triggers your body’s natural immune response, but can take weeks to develop enough antibodies and prevent some kinds of infection. Some vaccines for COVID-19 require two shots, so your body can develop its own immune response to the disease. But if you already have the virus, mAb treatment gives your body the antibodies it needs to protect itself.
HOW CAN I GET MONOCLONAL ANTIBODIES?
Patients who have had symptoms for 10 days or less should be referred for treatment by their healthcare providers and directed to available infusion locations.
WHAT IF I DON’T QUALIFY FOR MONOCLONAL ANTIBODY TREATMENT?
Your healthcare provider may decide you don’t qualify for mAb treatment. There could be several reasons for this. You may not meet all of the eligibility criteria, or you may have an underlying health condition that disqualifies you for mAb treatment.
Whatever the reason is, don’t give up. There could be another option. You may be able to join a clinical trial for COVID-19 treatments.
Participants in these clinical trials may receive new drugs or other treatments, so scientists can evaluate how well the treatments work. Thousands of participants in clinical trials have helped with the discovery of new treatments for COVID-19, and many more participants are needed to ensure that treatments work for people across age, gender, race, and ethnicity.
mAb treatment happens at an infusion center because the treatment is given through an intravenous (IV) infusion. Depending on the mAb treatment you receive, the whole process takes about 2 to 3 hours. First, medical staff conduct a screening; then they start an IV, which delivers the mAbs to your body in just over an hour. Afterward, the medical staff will have you stay at the infusion center for another hour to be sure you aren’t having an allergic reaction or other side effects. These reactions are rare, but the staff must observe you for this hour. Then you’ll be released to go home.
- Allergic reactions can happen during and after an antibody infusion. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever; chills; nausea; headache; shortness of breath; low blood pressure; wheezing; swelling of your lips, face, or throat; rash, including hives; itching; muscle aches; and/or dizziness.
mAb treatments for COVID-19, like other treatments authorized for emergency use by the U.S. Food and Drug Administration, are still being studied, so it's possible that we don’t know all the risks yet. As scientists continue to study the virus and how mAb treatment affects it, we’ll learn more about these possible risks. If you have any questions, please talk with your healthcare provider.
Learn more about Medicare coverage of COVID-19 treatment.
COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov combatcovid.hhs.gov/hcp/resources?twclid=11418279194082041862 — captured 2021-07-25
Early intervention with monoclonal antibody treatment may reduce the risk of severe illness and hospitalization for people with COVID-19 who are at high risk of developing more serious illness. Here are resources that can help you ensure rapid access to monoclonal antibody treatment for your high-risk COVID-19 patients.
The following documents provide promising practices and recommendations from provider organizations and states that have had success in increasing the utilization of COVID-19 monoclonal antibody treatments. These findings provide inspiration and information to those working to build treatment awareness and demand and can supplement individual plans and provide context to playbooks and planning discussions with leadership.
COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov combatcovid.hhs.gov/hcp/resources?twclid=11418295541604122625 — captured 2021-07-25
Early intervention with monoclonal antibody treatment may reduce the risk of severe illness and hospitalization for people with COVID-19 who are at high risk of developing more serious illness. Here are resources that can help you ensure rapid access to monoclonal antibody treatment for your high-risk COVID-19 patients.
The following documents provide promising practices and recommendations from provider organizations and states that have had success in increasing the utilization of COVID-19 monoclonal antibody treatments. These findings provide inspiration and information to those working to build treatment awareness and demand and can supplement individual plans and provide context to playbooks and planning discussions with leadership.
COVID-19 Vaccine Information | combatCOVID.hhs.gov combatcovid.hhs.gov/covid-19-vaccine-information — captured 2021-05-25
BREAKING NEWS:
The FDA has recently issued major updates to the Emergency Use Authorizations (EUA) for bamlanivimab and etesevimab administered together and REGEN-COV , both authorized for the treatment of mild to moderate COVID-19 in eligible patients. Please see the most recent FDA Fact Sheet ( bamlanivimab and etesevimab ) for Healthcare Providers.
FREQUENTLY ASKED QUESTIONS ABOUT THE COVID-19 VACCINE
WHAT IS THE COVID-19 VACCINE?
The COVID-19 vaccine is a product that helps your body protect itself against the virus that causes COVID-19 infection. The vaccine “teaches” your body’s immune system how to make antibodies specifically against the virus that causes COVID-19. If you come into contact with the virus, these antibodies give you a better chance of fighting it off and not becoming infected. The vaccine is given to you as an injection.
Three vaccines are available:
- The Pfizer-BioNTech COVID-19 vaccine uses part of the virus’s special genetic code (called messenger RNA or mRNA) to “teach” your body’s immune system how to make antibodies that defend your body against the virus that causes COVID-19. This vaccine is for people ages 16 and older. It requires two injections given 21 days apart. The second dose can be given up to 6 weeks after the first dose, if needed.
- The Moderna COVID-19 vaccine uses mRNA in the same way the Pfizer-BioNtech COVID-19 vaccine does. The Moderna vaccine is given to people ages 18 and older. It requires two injections given 28 days apart. The second dose can be given up to 6 weeks after the first dose, if needed.
- The Johnson & Johnson (J&J)/Janssen COVID-19 vaccine is a “vector” vaccine. Vector vaccines train your body to make antibodies in almost the same way the Moderna and Pfizer-BioNTech mRNA vaccines do. However, this type of vaccine uses a different type of genetic information (DNA) to “teach” your body how to defend itself against the virus. It is given to people ages 18 and older and requires one injection.
HOW COULD I BENEFIT FROM GETTING A COVID-19 VACCINE?
A COVID-19 vaccine may help:
- Prevent you from getting COVID-19, or if you get it, from becoming seriously ill or dying from COVID-19.
- Prevent you from spreading the virus that causes COVID-19 to other people, including loved ones or those who are at risk for serious illness from COVID-19.
- Help your community reach the goal of “herd” immunity. This means most people in a community have protection against the virus. Herd immunity helps prevent the spread of COVID-19.
- Prevent more variants or mutant strains of COVID-19 from developing by curbing the spread of the disease faster.
- Help everyone #CombatCOVID.
Once you’re fully vaccinated, you may be able to get back to doing some things you stopped doing because of the pandemic. For example, you can gather indoors, without masks, with other people who are fully vaccinated.
IS THE VACCINE SAFE?
The COVID-19 vaccines are considered safe and effective. They have been given Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) because researchers have closely studied the vaccines’ safety, effectiveness, and manufacturing quality. The vaccines have been given to millions of people in the United States. The Centers for Disease Control and Prevention (CDC) and the FDA will continue to monitor the vaccines for safety, but long-term side effects are unlikely. Severe allergic reactions to the vaccine are rare. If a reaction like this happened, it would likely happen while you’re at the location where you got the vaccine; that’s why you’re asked to wait a little while after getting your vaccine before you leave. If this type of reaction happens, vaccine providers can quickly and effectively treat it.
None of the vaccines cause you to become infected with the COVID-19 virus. None of the vaccines affect or become part of your genetic DNA.
AM I ELIGIBLE FOR THE VACCINE?
In each state in the United States, the COVID-19 vaccine has been made available to people in phases, beginning with people who are most vulnerable to being infected with the virus, and most vulnerable to getting very sick, due to their health, age, or because they are more likely to come in contact with the virus at their job. All people ages 16 and older in the United States are eligible for COVID-19 vaccines in the United States, including all 50 states and Washington, D.C.
WHAT IF I’M INTERESTED IN GETTING THE COVID-19 VACCINE AND...
● ... I’m at high risk for COVID-19 and I have pre-existing medical condition(s)? It’s important for adults of any age who have certain underlying medical conditions to get the COVID-19 vaccine, because they are at increased risk of getting very sick from COVID-19. People at high risk for severe (serious) COVID-19 include:
● Age : Older adults 65+ are at highest risk, with adults ages 85+ at the greatest risk. More than 80% of COVID-19 deaths have occurred in people over age 65.
● People of any age, race, ethnicity, and sex with certain underlying medical conditions such as:
- Overweight (defined as a body mass index [BMI]) of 25 or greater, obesity (BMI of 30– 39), or severe obesity (BMI of 40 or greater)
- Current or former cigarette smoker
- Pregnancy
- Diabetes type I or II
- Heart conditions such as heart failure, coronary artery disease, cardiomyopathies, and possibly high blood pressure (hypertension)
- Chronic kidney disease
- Chronic lung diseases, including chronic obstructive pulmonary disease (COPD), asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
- Dementia or other neurological conditions such as Alzheimer’s
- Cancer
- Down syndrome
- HIV/AIDS
- Weakened or immunocompromised immune system caused by conditions and/or treatments
- Chronic liver disease, such as alcohol-related liver disease, nonalcoholic fatty liver disease, and especially cirrhosis, or scarring of the liver
- Hemoglobin blood disorders such as sickle cell disease or thalassemia
- Received a solid organ transplant or blood stem cell transplant (includes bone marrow transplants)
- Cerebrovascular disease, such as having a stroke
- Substance use disorder such as alcohol, opioid, or cocaine use disorder
People with underlying medical conditions can receive a COVID-19 vaccine as long as they have not had a severe reaction to a COVID-19 vaccine, or to any of the individual ingredients in the vaccine.
If you’re considered high risk for severe COVID-19, you may also qualify for an ACTIV clinical trial for COVID-19 treatment or monoclonal antibody treatment. To learn how you can participate, please visit the Clinical Trials page or call 877-414-8106 to speak with an information specialist.
● ... I’ve already had COVID-19? Yes, you should get the vaccine even if you have already had COVID-19. The vaccine will help your body make enough antibodies against the COVID-19 virus to help prevent you from being infected again in the future. Even if you have already recovered from COVID-19, it’s possible that you could catch COVID-19 again. That’s because we don’t know yet how long a person is protected from getting sick again after they recover from COVID-19. The COVID-19 vaccine offers more help for your body to build the immunity that it might need.
● ... I have COVID-19 now? If you have tested positive for COVID-19, the CDC recommends that you isolate yourself (be alone) and use precautions (social distancing, wearing a face mask, washing your hands often, etc.) for 10 days after your COVID-19 symptoms start, or 10 days after you test positive for COVID-19—whichever happens first. Before you get the COVID-19 vaccine, you should wait until you do not have any COVID-19 symptoms, have isolated yourself for 10 days, and have not had a fever for 24 hours. At that point, clinical trial results indicate it’s safe for people who have had COVID-19 to get the vaccine.
If you already have COVID-19, consider joining an ACTIV clinical trial for COVID-19 treatments. Visit the Clinical Trials page to learn more.
● ... I’m pregnant?
- People who are pregnant have a higher risk of having worse COVID-19 symptoms than people who are not pregnant. If you’re pregnant, you may choose to be vaccinated. Vaccine monitoring systems for pregnancy are in place to monitor vaccine safety, and so far, they have not identified any specific safety concerns for pregnant people.
- There is no evidence that fertility problems are a side effect of any vaccine, including COVID-19 vaccines.
- If you have questions about getting vaccinated while you’re pregnant, a conversation with your healthcare provider could help.
- If you’re trying to become pregnant now or want to get pregnant in the future, you may receive a COVID-19 vaccine when one is available to you.
● ... I’ve received monoclonal antibody treatment?
- If you have recently received monoclonal antibody (mAb) treatment or convalescent plasma to treat COVID-19, the CDC recommends that you wait 90 days after that treatment before you get vaccinated. This also applies if you got sick with COVID-19 and received these treatments while you were waiting for your second dose of the vaccine.
- You should also wait 90 days after you get mAb treatment or convalescent plasma before you get your second dose of vaccine. Researchers are still studying the safety and effectiveness of COVID-19 vaccines for people who have received mAbs or convalescent plasma as part of COVID-19 treatment.
HOW DO I GET THE VACCINE?
You can receive your COVID-19 vaccine by scheduling an appointment online or by phone, or (in some places) by going to a drive-thru site. First, find a COVID-19 vaccine provider location near you by visiting https://vaccinefinder.gov .
You may be able to receive the vaccine at a doctor's office, hospital, urgent care center, community health center, state or local health department, mobile clinic, convention center, or cities' public health clinics, sports stadiums, or a retail pharmacy.
You can check your state/territory and local health departments' website for vaccine events and locations. To find your state's/territory’s health department website, visit https://www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html .
WHAT ELSE CAN I DO TO COMBAT COVID?
It’s important for people of all ages and communities to participate in clinical trials for COVID-19 treatments. This helps us find treatments and vaccines that are safe and effective for everybody. For more information about COVID-19 clinical trials, please visit the Clinical Trials page .
Social Media Toolkit | combatCOVID.hhs.gov combatcovid.hhs.gov/about-combat-covid/social-media-toolkit — captured 2021-10-24
SOCIAL MEDIA TOOLKIT
Looking to get the word out about Combat COVID through your social media channels? The Combat COVID social media toolkit has ready-to-go messages for Facebook , Twitter , Instagram , and LinkedIn . Simply click the graphics to view or download them. Keep these tips in mind:
- Feel free to incorporate relevant local hashtags along with #CombatCOVID to reach your target audience.
- URLs are not active when posted in Instagram captions, opt for sharing them in your profile bio.
- Use a URL shortener like Bitly for link metrics and to shorten long URLs.
SOCIAL MEDIA MESSAGES AND IMAGES
SOCIAL MEDIA MESSAGES
Ready-to-use COMBAT COVID posts for your social media channels.
For reliable and up-to-date COVID-19 information and resources, visit #CombatCOVID: https://go.usa.gov/x6uqY. Learn how you can help us get back to normal.
We all have a part to play in ending COVID-19. Find resources and updates about vaccines, treatments, and research at https://go.usa.gov/x6uqY. #CombatCOVID
Together, we can beat COVID-19. Help us share the latest facts and resources about vaccines, treatments, and research—visit: https://go.usa.gov/x6uqY. #CombatCOVID
Combat COVID is your one-stop resource for the latest information and resources on vaccines, treatments, and research. Take action against COVID-19 now—visit: https://go.usa.gov/x6uqY. #CombatCOVID
Help your community #CombatCOVID by sharing up-to-date and accurate COVID-19 information. Get resources on vaccines, treatments, and COVID-19 research—visit: https://go.usa.gov/x6uqY.
Combat COVID has the answers to your urgent COVID-19 questions. Learn the latest information and resources by visiting https://go.usa.gov/x6uqY. #CombatCOVID
Vaccines are just the beginning. Learn the latest updates on COVID-19 and how you can take action—visit: https://go.usa.gov/x6uqY. #CombatCOVID
SOCIAL MEDIA IMAGES
To download an image and save the file to your computer, click on the link for the platform you want to use.
GIFS
====================================================================== Monoclonal Antibodies for High-Risk COVID-19 Positive Patients | combatCOVID.hhs.gov combatcovid.hhs.gov/i-have-covid-19-now/monoclonal-antibodies-high-risk-covid-19-positive-patients?gclid=Cj0KCQiA34OBBhCcARIsAG32uvOY7s-pBhKSSkSTtM4NQyFnmjqB5CKsjp1OJx6qZPYOXIC78Z7RUWAaAlRGEALw_wcB — captured 2021-11-29 ======================================================================
If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.
Some early evidence suggests that mAb treatment can reduce the amount of the SARS-CoV-2 virus (the virus that causes COVID-19) in a person's system. This amount is known as viral load. Having a lower viral load means you may have milder symptoms thereby decreasing the likelihood of you needing to stay in the hospital.
mAb treatment may help people who:
- Have a positive COVID-19 test, and had symptoms for 10 days or less
- Are at high risk of getting more serious symptoms
Visit the page How Do I Know If I’m High Risk, and What Do I Do Next? to learn more.
This page describes what mAbs are, how they can prevent mild to moderate symptoms from getting worse, and what to expect if you get mAb treatment.
Find infusion locations
Have symptoms, but no healthcare provider? Call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585.
The Drug Trial That Could Actually Produce Covid Treatments
Why Monoclonal Antibody COVID Therapies Have Not Lived Up to Expectations
Where Are We in the Quest for Coronavirus Treatments?
Labcorp and the U.S. Department of Health and Human Services Join Forces to Raise Awareness of COVID-19 Treatments
Researchers fear people of color may be disproportionately affected by long Covid
How the Corporate World, Government Worked Together to Deliver a Solution to the COVID-19 Pandemic
LOCAL NEWS
Michigan Expands Monoclonal Antibodies Treatment To Cut Hospitalizations, Deaths
Monoclonal Antibodies Can Cut Risk Of Hospitalization, Death By 70% In COVID-19 Patients
'Like Somebody Gave Me A Happy Pill': Monoclonal Antibodies Help Americans Most At Risk For COVID-19
UPMC Hamot Offering Monoclonal Antibodies For Patients Diagnosed With COVID-19
Your body naturally makes antibodies to fight infection. However, your body may not have antibodies designed to recognize a novel (or new) virus like SARS-CoV-2, the virus that causes COVID-19. Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection—in this case, SARS-CoV-2—and are given to patients directly with an infusion. That’s why mAb treatment may help patients who are at high risk for serious symptoms or having to stay in the hospital.
mAb treatment for COVID-19 is different from a COVID-19 vaccine. A vaccine triggers your body’s natural immune response, but can take weeks to develop enough antibodies and prevent some kinds of infection. Some vaccines for COVID-19 require two shots, so your body can develop its own immune response to the disease. But if you already have the virus, mAb treatment gives your body the antibodies it needs to protect itself.
HOW CAN I GET MONOCLONAL ANTIBODIES?
People who have had symptoms for 10 days or less should be referred for treatment by their healthcare providers and directed to available infusion locations. If you do not have a healthcare provider , call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.
There is no cost to anyone for the antibodies themselves, but there may be treatment fees. If you do not have insurance, ask the facility if there will be a charge.
WHAT IF I DON’T QUALIFY FOR MONOCLONAL ANTIBODY TREATMENT?
Your healthcare provider may decide you don’t qualify for mAb treatment. There could be several reasons for this. You may not meet all of the eligibility criteria, or you may have an underlying health condition that disqualifies you for mAb treatment.
Whatever the reason is, don’t give up. There could be another option. You may be able to join a clinical trial for COVID-19.
Participants in these clinical trials may receive new drugs or other treatments, so researchers can evaluate how well the treatments work. Thousands of participants in clinical trials have helped with the discovery of new treatments for COVID-19, and many more participants are needed to make sure that treatments work for people across age, gender, race, and ethnicity.
mAb treatment happens at an infusion center because the treatment is given through an intravenous (IV) infusion. Depending on the mAb treatment you receive, the whole process takes about 2 to 3 hours. First, medical staff conduct a screening; then they start an IV, which delivers the mAbs to your body in just over an hour. Afterward, the medical staff will have you stay at the infusion center for another hour to be sure you aren’t having an allergic reaction or other side effects. These reactions are rare, but the staff must observe you for this hour. Then you’ll be released to go home.
- Allergic reactions can happen during and after an antibody infusion. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever; chills; nausea; headache; shortness of breath; low blood pressure; wheezing; swelling of your lips, face, or throat; rash, including hives; itching; muscle aches; and/or dizziness.
mAb treatments for COVID-19, like other treatments authorized for emergency use by the U.S. Food and Drug Administration, are still being studied, so it's possible that we don’t know all the risks yet. As researchers continue to study the virus and how mAb treatment affects it, we’ll learn more about these possible risks. If you have any questions, please talk with your healthcare provider.
Learn more about Medicare coverage of COVID-19 treatment.
MONOCLONAL ANTIBODY TREATMENT LOCATOR
Use this tool to find out if you or a loved one may qualify for monoclonal antibody (mAb) treatment and, if you do qualify, how you can get mAb treatment. If you’re high risk, talk to your healthcare provider about mAb treatment.
====================================================================== Monoclonal Antibodies for High-Risk COVID-19 Positive Patients | combatCOVID.hhs.gov combatcovid.hhs.gov/i-have-covid-19-now/monoclonal-antibodies-high-risk-covid-19-positive-patients?gclid=Cj0KCQiA-aGCBhCwARIsAHDl5x91slr99GiHMDTqGgA4UHr0yP-GAg4UIK-r27qBOnA0gRdXZv9S00AaAqltEALw_wcB — captured 2021-11-29 ======================================================================
If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.
Some early evidence suggests that mAb treatment can reduce the amount of the SARS-CoV-2 virus (the virus that causes COVID-19) in a person's system. This amount is known as viral load. Having a lower viral load means you may have milder symptoms thereby decreasing the likelihood of you needing to stay in the hospital.
mAb treatment may help people who:
- Have a positive COVID-19 test, and had symptoms for 10 days or less
- Are at high risk of getting more serious symptoms
Visit the page How Do I Know If I’m High Risk, and What Do I Do Next? to learn more.
This page describes what mAbs are, how they can prevent mild to moderate symptoms from getting worse, and what to expect if you get mAb treatment.
Find infusion locations
Have symptoms, but no healthcare provider? Call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585.
The Drug Trial That Could Actually Produce Covid Treatments
Why Monoclonal Antibody COVID Therapies Have Not Lived Up to Expectations
Where Are We in the Quest for Coronavirus Treatments?
Labcorp and the U.S. Department of Health and Human Services Join Forces to Raise Awareness of COVID-19 Treatments
Researchers fear people of color may be disproportionately affected by long Covid
How the Corporate World, Government Worked Together to Deliver a Solution to the COVID-19 Pandemic
LOCAL NEWS
Michigan Expands Monoclonal Antibodies Treatment To Cut Hospitalizations, Deaths
Monoclonal Antibodies Can Cut Risk Of Hospitalization, Death By 70% In COVID-19 Patients
'Like Somebody Gave Me A Happy Pill': Monoclonal Antibodies Help Americans Most At Risk For COVID-19
UPMC Hamot Offering Monoclonal Antibodies For Patients Diagnosed With COVID-19
Your body naturally makes antibodies to fight infection. However, your body may not have antibodies designed to recognize a novel (or new) virus like SARS-CoV-2, the virus that causes COVID-19. Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection—in this case, SARS-CoV-2—and are given to patients directly with an infusion. That’s why mAb treatment may help patients who are at high risk for serious symptoms or having to stay in the hospital.
mAb treatment for COVID-19 is different from a COVID-19 vaccine. A vaccine triggers your body’s natural immune response, but can take weeks to develop enough antibodies and prevent some kinds of infection. Some vaccines for COVID-19 require two shots, so your body can develop its own immune response to the disease. But if you already have the virus, mAb treatment gives your body the antibodies it needs to protect itself.
HOW CAN I GET MONOCLONAL ANTIBODIES?
People who have had symptoms for 10 days or less should be referred for treatment by their healthcare providers and directed to available infusion locations. If you do not have a healthcare provider , call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.
There is no cost to anyone for the antibodies themselves, but there may be treatment fees. If you do not have insurance, ask the facility if there will be a charge.
WHAT IF I DON’T QUALIFY FOR MONOCLONAL ANTIBODY TREATMENT?
Your healthcare provider may decide you don’t qualify for mAb treatment. There could be several reasons for this. You may not meet all of the eligibility criteria, or you may have an underlying health condition that disqualifies you for mAb treatment.
Whatever the reason is, don’t give up. There could be another option. You may be able to join a clinical trial for COVID-19.
Participants in these clinical trials may receive new drugs or other treatments, so researchers can evaluate how well the treatments work. Thousands of participants in clinical trials have helped with the discovery of new treatments for COVID-19, and many more participants are needed to make sure that treatments work for people across age, gender, race, and ethnicity.
mAb treatment happens at an infusion center because the treatment is given through an intravenous (IV) infusion. Depending on the mAb treatment you receive, the whole process takes about 2 to 3 hours. First, medical staff conduct a screening; then they start an IV, which delivers the mAbs to your body in just over an hour. Afterward, the medical staff will have you stay at the infusion center for another hour to be sure you aren’t having an allergic reaction or other side effects. These reactions are rare, but the staff must observe you for this hour. Then you’ll be released to go home.
- Allergic reactions can happen during and after an antibody infusion. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever; chills; nausea; headache; shortness of breath; low blood pressure; wheezing; swelling of your lips, face, or throat; rash, including hives; itching; muscle aches; and/or dizziness.
mAb treatments for COVID-19, like other treatments authorized for emergency use by the U.S. Food and Drug Administration, are still being studied, so it's possible that we don’t know all the risks yet. As researchers continue to study the virus and how mAb treatment affects it, we’ll learn more about these possible risks. If you have any questions, please talk with your healthcare provider.
Learn more about Medicare coverage of COVID-19 treatment.
MONOCLONAL ANTIBODY TREATMENT LOCATOR
Use this tool to find out if you or a loved one may qualify for monoclonal antibody (mAb) treatment and, if you do qualify, how you can get mAb treatment. If you’re high risk, talk to your healthcare provider about mAb treatment.
====================================================================== FAQs: Clinical Trials For COVID-19 | combatCOVID.hhs.gov combatcovid.hhs.gov/clinical-trial-toolkit-healthcare-professionals/faqs-clinical-trials-covid-19 — captured 2021-10-19 ======================================================================
FAQS: CLINICAL TRIALS FOR COVID-19
HOW CAN I EXPLAIN CLINICAL TRIALS TO MY PATIENTS?
Participants are assigned to one or more therapeutic interventions (which may include a placebo or other control) to evaluate the safety and efficacy of a particular treatment. Clinical trials help discover new or better ways to prevent, treat, or cure disease.
HOW ARE THE ACTIV CLINICAL TRIALS DIFFERENT?
ACTIV clinical trials use an innovative adaptive platform trial design to test multiple therapies simultaneously and quickly remove treatments that have been proven less effective.
HOW CAN I HELP MY PATIENTS CONSIDER PARTICIPATION IN A CLINICAL TRIAL?
You can find current COVID-19 and ACTIV clinical trial resources on this website . For more information about patient enrollment, call 1-877-414-8106 or use the chat feature .
IS MY REFERRAL REQUIRED FOR ENROLLMENT?
No, a formal referral is not required for ACTIV clinical trial participation. However, you can connect your patient to valuable resources on Combat COVID to help them consider options for COVID-19 clinical trials.
HOW IS MY PATIENT’S CARE MANAGED IN ACTIV CLINICAL TRIALS?
Participants are carefully pre-screened to determine safe eligibility. The principal investigator (PI) manages and assesses all participants’ care throughout the clinical trial. Safety and efficacy of therapeutic interventions are monitored during and after completion of participation.
WHAT ARE THE POTENTIAL RISKS AND BENEFITS OF MY PATIENT’S ENROLLMENT?
As with any clinical trial or therapy administered, there can be potential risks and benefits involved. These are specific to each clinical trial and are reviewed during the consent process with participants. However, COVID-19 patients could have access to more treatment options sooner through clinical trials. Visit the Combat COVID Clinical Trials page to review available clinical trial options or call 1-877-414-8106 to speak to a live medical information specialist about you or your patient’s ACTIV trial questions.
HOW CAN MY PATIENTS’ CONTINUUM OF CARE BE MAINTAINED?
Participants can request to have any eligible records from a clinical trial sent to their primary healthcare provider for continuity of care. Personal health information is confidential, and any eligible records will not be shared unless a participant completes a medical records request.
WHERE CAN MY PATIENT REPORT ANY SIDE EFFECTS DURING THE CLINICAL TRIAL?
Participants are instructed to report any side effects or symptoms experienced during or after a clinical trial to the PI or research site. The PI will report all adverse events (suspected or unexpected) to the study sponsor and the U.S. Food and Drug Administration.
WILL CLINICAL TRIALS INTERFERE WITH ANY OF MY CURRENT MANAGEMENT OF PATIENTS’ CHRONIC CONDITIONS?
Your patient will be asked to continue their care with their primary and specialty healthcare providers in collaboration with the research team. If your patient is considering ACTIV clinical trial participation, it is essential to contact any potential clinical trials before prescribing any treatments for COVID-19. All prescribed therapies for managed chronic conditions will be continued, unless contraindicated.
IMPORTANCE OF COVID-19 CLINICAL TRIALS: WHY SHOULD PATIENTS PARTICIPATE?
WHY IS IT IMPORTANT TO ENROLL PATIENTS IN CLINICAL TRIALS FOR COVID-19?
ACTIV clinical trials for COVID-19 may help us to:
Note: Patients are only eligible for monoclonal antibody treatment within 10 days of testing positive for COVID-19.
- Provide potential treatment options for patients who have not received the COVID-19 vaccine.
- Reduce symptom severity and decrease the risk for severe outcomes or deaths.
- Find symptom alleviation for recovered COVID-19 patients who are experiencing long-term effects from COVID-19.
- Explore more accessible, feasible COVID-19 treatment and prevention options for all patient populations.
- Continue efforts to combat emerging variants of COVID-19.
- Expand the timeframe of delivery for COVID-19 treatment options.
FAQS: CLINICAL TRIALS FOR COVID-19 TREATMENTS
IF MY PATIENT ENROLLS, CAN THEY CHOOSE TO WITHDRAW PARTICIPATION AFTER ENROLLMENT?
Participants can decide to exit a clinical trial at any time for any reason. If they discontinue enrollment before the study ends, a medical team will continue to monitor them and complete follow ups to ensure safety and continuity of care.
IS PATIENT PARTICIPATION IN A CLINICAL TRIAL COVERED BY INSURANCE?
Clinical trial participation is offered at no cost to the patient through the site sponsor and government funding and is not financed through insurance. Patients who enroll in a clinical trial will not receive a bill for their participation.
YOUR ROLE AS A HEALTHCARE PROVIDER
HOW CAN I BECOME MORE INVOLVED IN CLINICAL TRIALS OR FINDING COVID-19 TREATMENTS?
Learn about ACTIV clinical trials and help COVID-19 patients explore available clinical trial options at CombatCOVID.hhs.gov or call the ACTIV trial call center at 1-877-414-8106. Scientists and organizations can also make submissions for vaccines and therapeutic ideas for COVID-19 through the National Institutes of Health COVID-19 Candidate and Technologies Portal .
IF I SPEAK SPANISH OR MY PATIENT’S PRIMARY LANGUAGE IS NOT ENGLISH CAN I STILL REFER PATIENTS TO PARTICIPATE IN A CLINICAL TRIAL?
Yes! Information about the ACTIV trials is available in Spanish at https://CombateCOVID.hhs.gov . Spanish-speaking information specialists are also available to answer questions about the ACTIV trials at 1-877-414-8106.
Available COVID-19 Treatment Options | combatCOVID.hhs.gov combatcovid.hhs.gov/available-covid-19-treatment-options — captured 2021-10-11
AVAILABLE COVID-19 TREATMENT OPTIONS
If you or a loved one test positive for COVID-19, you may now have treatment options. COVID-19 treatment options are available for patients with mild to moderate symptoms and for patients in the hospital. Mild symptoms may include fever, cough, sore throat, malaise (feeling unwell), headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste and smell. Moderate symptoms may also include shortness of breath.
Continue reading — 634 more paragraphs
Preservation is not endorsement. The Free Knowledge Library preserves primary sources from across the political spectrum. Keeping a document does not mean we agree with it. What the labels mean.