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CLINICAL TRIALS

For more information about joining a clinical trial:

Call 877-414-8106

 

The gold standard for testing drug treatments in people is the randomized, double-blind, placebo-controlled clinical trial. These clinical trials are the fastest and most rigorous way to find successful treatments for COVID-19. In these trials, participants are assigned randomly to either a test group that receives the drug being tested, or to a control group that receives a placebo, which is a treatment that has none of the active drug in it. Over 5,000 people have participated in the clinical trials listed below.

Learn About the Basics of Clinical Trials

 


CLINICAL TRIALS FOR ADULT PATIENTS WHO ARE NOT HOSPITALIZED

People who have tested positive for COVID-19 but have symptoms that are mild enough to allow them to recover at home can participate in certain clinical trials. The following trials are for patients who are not in the hospital.

 

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.

For more information:

VISIT RISEABOVECOVID.ORGCALL 1-877-414-6404

ACTIV-4: (ACTIV-4B) Determining how effective blood thinners are in reducing blood clots in adults diagnosed with COVID-19.

What drugs are being tested in this trial?
Antithrombotics (blood thinners).

What is the type of clinical trial being conducted?
Randomized, open-label study.

About this study:
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-4B for patients who are not hospitalized:

This clinical trial is assessing whether blood-thinning treatment can reduce life-threatening heart, lung, or circulation complications in newly diagnosed COVID-19 patients who do not need hospital care. Participants will receive the blood thinner apixaban (Eliquis), aspirin, or a placebo.

For more information:

VISIT NHLBI-CONNECTS.ORG/ACTIV4BCALL 1-800-664-0637

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.

Learn moreCall 1-833-385-1880

CONVALESCENT PLASMA TO LIMIT COVID-19 ASSOCIATED COMPLICATIONS: Determining if convalescent plasma can prevent hospitalizations and keep symptoms from worsening

What treatment is being tested?
COVID-19 convalescent plasma.

What type of study is this?
COVID-19 convalescent plasma, also known as “survivor’s plasma,” is blood plasma donated by patients who have recovered from COVID-19. More than 600,000 Americans have received COVID-19 convalescent plasma as a treatment. It contains antibodies, or special proteins generated by the body’s immune system to fight infections caused by viruses or other pathogens. This clinical trial explores the safety and efficacy of convalescent plasma for treatment of COVID-19 in preventing hospitalizations and stopping progression of symptoms. Adults 18 and older who test positive for COVID-19 and are within 8 days of onset of symptoms are eligible for enrollment. Participants with underlying illness or who are pregnant and breastfeeding are eligible to participate. Participants will be tested for antibody responses at 2, 4, and 12-week visits. This is a randomized, double-blind, placebo control trial.

For more information:

VISIT COVIDPLASMATRIAL.ORGCALL 1-800-664-0637

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 hyperimmunoglobulin (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 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.

For more information:

EMAIL [email protected]CALL 877-414-7243

 


CLINICAL TRIALS FOR ADULTS WHO HAVE BEEN EXPOSED TO COVID-19 BUT HAVE NOT DEVELOPED THE DISEASE

 

CONVALESCENT PLASMA TO PREVENT OR STEM COVID-19 INFECTION AFTER EXPOSURE TO THE NOVEL CORONAVIRUS

What treatments are being tested in this trial?
COVID-19 convalescent plasma.

What is the type of clinical trial being conducted?
Randomized, double-blind, placebo control trial.

About this trial:
COVID-19 convalescent plasma, also known as “survivor’s plasma,” is blood plasma donated by patients who have recovered from COVID-19. More than 600,000 Americans have received COVID-19 convalescent plasma as a treatment. It contains antibodies, or special proteins generated by the body’s immune system to fight infections caused by viruses or other pathogens. This clinical trial assesses the safety and efficacy of convalescent plasma treatment for adults who have been exposed to someone who has tested positive for COVID-19 but who test negative themselves and who do not have any symptoms. Those who develop COVID-19 after receiving convalescent plasma treatment will be followed for 4 weeks and tested for antibody responses at 12 weeks.

For more information:

VISIT COVIDPLASMATRIAL.ORGCALL 1-888-506-1199

 


CLINICAL TRIALS FOR ADULT HOSPITALIZED PATIENTS

If someone you know is being treated for COVID-19 in the hospital, there are several clinical trials they may be able to participate in. Ask their doctor or other health care provider to look into these trials.

 

ACTIV-1

What treatments are being tested in this trial?
Immune modulators + 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 severe 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 hospitalized patients. 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.

For more information:

VISIT ACTIV-1.ORGCALL 877-384-6573

ACTIV-3

What drugs are being tested in this trial?
Monoclonal antibodies (additional drugs may be added later).

What is the type of clinical trial being conducted?
Randomized, double-blind, placebo-controlled trials.

About this trial:
This trial is enrolling adult patients being treated in the hospital for COVID-19 and will assess how well monoclonal antibodies plus standard treatment perform, versus standard treatment alone. Monoclonal antibodies are laboratory-made versions of proteins naturally produced by the immune system to respond to infections caused by viruses or other pathogens. Standard treatment for hospitalized patients includes the antiviral drug remdesivir (Veklury), which reduces the ability of viruses to multiply in the body. The clinical trial is assessing safety and whether the antibody treatment can reduce time to recovery i.e., “get home and stay home.”

The chance of receiving an experimental antibody treatment or standard treatment will depend on how many antibody treatments are being studied when a patient enrolls. If there are two experimental treatments, patients have a 2 in 3 chance of receiving an experimental treatment and 1 in 3 chance of standard treatment; if there are three experimental treatments, patients have 3 in 4 chance of receiving an experimental treatment and 1 in 4 of standard treatment; and so on. While ACTIV-3 is starting with investigating monoclonal antibodies, other drugs may be added in the future.

For more information:

CALL 877-414-7243

ACTIV-3b: 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 hospitalized with COVID-19 but it is not known if it will help people with severe 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 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.

For more information:

EMAIL [email protected]CALL 877-414-7243

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 HOSPITALIZED PATIENTS
This clinical trial for patients who are hospitalized for 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 hospitalized patients that reduces the ability of viruses to multiply in the body.

For more information:

CALL 1-800-664-0637

ACTIV-5

What investigational drugs are being tested in this study?
Investigational drug: several 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 in patients hospitalized 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.

For information, a doctor or other healthcare provider can:

CALL 301-761-7948EMAIL [email protected]

PASSITONII (PASSIVE IMMUNITY TRIAL OF THE NATION FOR COVID-19)

What treatments are being tested?
COVID-19 convalescent plasma.

What is the type of clinical trial being conducted?
Randomized, triple-blind, placebo-controlled trial.

About this trial:
COVID-19 convalescent plasma, also known as “survivor’s plasma,” is blood plasma derived from people who have recovered from COVID-19. More than 600,000 Americans have received COVID-19 convalescent plasma as a treatment. It contains antibodies, or special proteins generated by the body’s immune system to fight infections caused by viruses or other pathogens. This clinical trial will assess the safety and effectiveness of convalescent plasma in hospitalized patients with acute respiratory symptoms.

For information, a doctor or other health care provider can:

VISIT PASSITONSTUDY.ORGEMAIL [email protected]

INTERLEUKIN PULMONARY (iLeukPulm) STUDY OF SARGRAMOSTIM IN PATIENTS WITH COVID-19

What treatments are being tested?
Sargramostim

What is the type of clinical trial being conducted?
Randomized, open-label study

About this trial:
The iLeukPulm study is testing if inhaled sargramostim can help adult hospitalized patients recover faster from COVID-19. Patients randomized to the sargramostim arm will be treated with inhaled sargramostim twice a day for 5 days, in addition to their standard COVID-19 treatment. All patients in the study will continue to get standard COVID-19 care and treatment. Sargramostim is a man-made version of a protein called granulocyte-macrophage colony stimulating factor (GM-CSF). GM-CSF is a type of immune modulator (a protein that sends signals to immune cells) that is critical for healthy lung function and for helping our immune cells fight infections. Sargramostim is FDA-approved to help patients recover from certain cancer treatments and to treat victims of radiation exposure.

For information:

EMAIL [email protected]

 


CLINICAL TRIAL FOR ADULT PATIENTS WHO HAVE BEEN DISCHARGED FROM THE HOSPITAL

If you have been hospitalized for COVID-19 but are now recovering at home or in a rehabilitation facility, you may be eligible to participate in a clinical trial.

 

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.

For more information:

CALL 1-800-664-0637

 


CLOSED CLINICAL TRIALS

 

C3PO (COVID-19 CONVALESCENT PLASMA CLINICAL TRIAL)

What treatments are being tested in this trial?
COVID-19 convalescent plasma.

What is the type of clinical trial being conducted?
Randomized, single-blind, placebo-controlled trial.

About this trial:
COVID-19 convalescent plasma, also known as “survivor’s plasma,” is blood plasma donated by patients who have recovered from COVID-19. More than 600,000 Americans have received COVID-19 convalescent plasma as a treatment. It contains antibodies, or special proteins generated by the body’s immune system to fight infections caused by viruses or other pathogens. This clinical trial explores the safety and effectiveness of COVID-19 convalescent plasma in treating patients seen in emergency departments who have recently (within the last week) developed mild to moderate symptoms of COVID-19 and have one or more risk factors of progressing to a severe form of COVID-19, including hypertension, diabetes, heart disease, or chronic lung disease. The C3PO trial will determine whether transfusions (transferring blood products into a person’s circulation) with COVID-19 convalescent plasma can prevent the relatively mild to moderate symptoms in this vulnerable group from developing into more serious illness when given early in the course of the disease. It also will assess the safety of the plasma transfusion itself.

For more information

VISIT SIREN.NETWORK

CONTAIN COVID-19 (CONVALESCENT PLASMA TO LIMIT COVID-19 COMPLICATIONS IN HOSPITALIZED PATIENTS)

What treatments are being tested?
COVID-19 convalescent plasma.

What is the type of clinical trial being conducted?
Randomized, double-blind, placebo-controlled trial.

About this trial:
COVID-19 convalescent plasma, also known as “survivor’s plasma,” is blood plasma derived from people who have recovered from COVID-19. More than 600,000 Americans have received COVID-19 convalescent plasma as a treatment. It contains antibodies, or special proteins generated by the body’s immune system to fight infections caused by viruses or other pathogens. This clinical trial will assess the safety and effectiveness of convalescent plasma in hospitalized patients with acute respiratory symptoms and who may require oxygen.

For information, a doctor or other health care provider can:

VISIT MED.NYU.EDU

INPATIENT TREATMENT WITH ANTI-CORONAVIRUS IMMUNOGLOBULIN (ITAC)

What drugs are being tested?
Hyperimmune intravenous immunoglobulin (HIVIG) + remdesivir (veklury).

What is the type of clinical trial being conducted?
Randomized, double-blind, placebo-controlled trial.

About this trial:
ITAC is testing a combination treatment for COVID-19 to determine if it can increase the natural antibody response to the virus and reduce the risk of more serious illness and death. The treatment consists of the FDA-approved antiviral remdesivir (Veklury) plus a highly concentrated solution of antibodies that neutralize the virus that causes COVID-19. Antivirals like remdesivir reduce the ability of viruses to multiply in the body. The antibody solution contains several times more virus-neutralizing antibodies, which have also been highly purified, than typically found in the plasma of people who have recovered from COVID-19.

MONOCLONAL ANTIBODIES TO PREVENT COVID-19 INFECTION BEFORE EXPOSURE TO THE NOVEL CORONAVIRUS

What treatment is being tested?
Monoclonal antibodies.

What is the type of clinical trial being conducted?
Randomized, double-blinded, placebo-controlled study.

What type of study is this?
The study is looking at how well monoclonal antibodies work and how safe they are. Monoclonal antibodies are laboratory-made versions of proteins naturally produced by the immune system to respond to infections caused by viruses or other pathogens. This trial is enrolling adult participants before they are exposed to SARS-COV-2 and will assess the safety and effectiveness of the investigational antibodies to prevent COVID-19 compared to placebo. In this study, you will receive two study injections, at one time, of either the investigational monoclonal antibodies or placebo. One in two study participants (33%) will get placebo and two in three participants (66%) will get the investigational antibodies.

For more information:

VISIT C19PROVENTSTUDY.COM

MONOCLONAL ANTIBODIES TO STEM COVID-19 INFECTION AFTER EXPOSURE TO THE NOVEL CORONAVIRUS

What treatments are being tested in this trial?
Monoclonal antibodies.

What is the type of clinical trial being conducted?
Randomized, open-label study.

About this trial:
The study is looking at how well monoclonal antibodies work and how safe they are. Monoclonal antibodies are laboratory-made versions of proteins naturally produced by the immune system to respond to infections caused by viruses or other pathogens. This trial is enrolling adult patients who have been exposed to SARS-COV-2 and will assess the safety and effectiveness of the investigational antibodies to prevent COVID-19 after exposure to the virus compared to placebo. In this study, you will receive two study injections, at one time, of either the investigational monoclonal antibodies or placebo. One in three study participants (33%) will get the placebo and two in three participants (66%) will get the investigational antibodies.

For more information

VISIT C19PROVENTSTUDY.COMLEARN MORE HERE [PDF]

ADAPTIVE COVID-19 TREATMENT TRIAL 4 (ACTT-4)

What drugs are being tested?
Baricitinib vs dexamethasone, both with remdesivir.

What is the type of clinical trial being conducted?
Randomized, double-blind, placebo-controlled trial.

About this trial:
ACTT-4 aims to determine whether baricitinib, an FDA-approved anti-inflammatory drug for rheumatoid arthritis, or dexamethasone, a corticosteroid available as a generic drug, when administered with remdesivir, is more effective at preventing hospitalized adults on supplemental oxygen from progressing to requiring mechanical ventilation or dying, among other outcomes, or if they are similar. Remdesivir is a broad-spectrum antiviral recently approved by the FDA for treatment of hospitalized COVID-19 patients aged 12 years and older. On November 19, FDA granted Emergency Use Authorization (EUA) for baricitinib to be used in combination with remdesivir in hospitalized COVID-19 patients aged 2 years and older who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Participants will be assigned at random to one of two treatment arms of equal size. The trial is blinded for the dexamethasone and baricitinib components, meaning investigators and participants will not know who is receiving dexamethasone and who is receiving baricitinib. Dexamethasone is administered by intravenous (IV) infusion, and baricitinib is a tablet taken orally. Therefore, one group will receive oral baricitinib tablets and an IV placebo, and the other group will receive IV dexamethasone and oral placebo tablets. All participants will receive intravenous remdesivir.