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JOIN A CLINICAL TRIAL FOR COVID TREATMENTS

Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for COVID-19 and other conditions.

Call 877-414-8106


WHAT ARE CLINICAL TRIALS?

Clinical trials are research studies in which volunteers receive new drugs or other treatments so that scientists can evaluate how well the treatments work. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. In addition to taking the drugs or treatments being tested, participants may help measure results by reporting on how they feel and by allowing providers to conduct follow-up exams that might include blood tests or other testing.

Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test safety and performance. If these studies show favorable results, the FDA gives approval for the treatment to be tested in humans, beginning with a very small participant population to test safety.

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Graphic of a family wearing masks.

WHAT KINDS OF TRIALS ARE STUDYING TREATMENTS FOR COVID-19?

Many scientists around the world are testing treatments for COVID-19. The National Institutes of Health (NIH) has set up a partnership among government, industry, and university researchers to identify drugs and other treatments that are most promising. These are called ACTIV trials. Five ACTIV trials are under way in many different locations and four other trials with similar designs and goals are associated with ACTIV. The treatments under study in these trials are for patients at every stage of illness – at home (outpatient), in the hospital (inpatient), or in recovery (convalescent) for patients recently discharged from the hospital.

WHY SHOULD I PARTICIPATE IN AN ACTIV CLINICAL TRIAL IF I HAVE COVID-19?

Clinical trials are at the heart of all medical advances. There are many clinical trials in hospitals and other health care settings testing treatments for COVID-19, but not all of them are at advanced stages of testing or designed like ACTIV or ACTIV-associated trials. When you join an ACTIV or ACTIV-associated clinical trial, you get access to experimental drugs that already have been tested for safety in smaller populations. As with all clinical trials, you will be closely monitored by the study team for the duration of the trial. When you join these clinical trials your participation will contribute to a better scientific understanding of COVID-19 and lead to treatments that will help others.

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Syringe icon

WHAT IS A RANDOMIZED, DOUBLE-BLIND,  PLACEBO- CONTROLLED CLINICAL TRIAL?

 

 

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. Both groups also receive other care that is standard for their stage of COVID-19 illness. Because neither the participant nor the doctor knows whether the treatment is the drug or the placebo, they are called “double-blind” trials. This double blinding prevents members of the research team and study participants from influencing the results. Only a group of scientists who are part of a separate team, the Data Safety Monitoring Board, knows what participants received. This team closely monitors the safety of all participants.

HOW DO I JOIN AN ACTIV CLINICAL TRIAL?

Choosing to join a clinical trial is an important personal decision. Talk with your doctor about joining a clinical trial.

You may also call to get more information about joining an ACTIV or ACTIV-associated clinical trial.

A real person will answer your questions and help you navigate the options.

Call 877-414-8106

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
 

  • DRUGS BEING TESTED: MULTIPLE DIFFERENT MEDICINES AGAINST COVID-19
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 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.

Visit RiseAboveCovid.org Call 1-877-414-6404

ACTIV-4
 

  • DRUGS BEING TESTED: ANTITHROMBOTICS (BLOOD THINNERS)
  • RANDOMIZED, OPEN-LABEL 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.

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.

CONVALESCENT PLASMA TO LIMIT COVID-19 ASSOCIATED COMPLICATIONS
 

  • TREATMENT BEING TESTED: COVID-19 CONVALESCENT PLASMA
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROL 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 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.

Visit CovidPlasmaTrial.org Call 1-888-506-1199

CLINICAL TRIAL FOR PERSONS 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
 

  • TREATMENT BEING TESTED: COVID-19 CONVALESCENT PLASMA
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROL 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.

Visit CovidPlasmaTrial.org Call 1-888-506-1199

MONOCLONAL ANTIBODIES TO STEM OR PREVENT COVID-19 INFECTION AFTER EXPOSURE TO THE NOVEL CORONA VIRUS

  • TREATMENT BEING TESTED: MONOCLONAL ANTIBODIES
  • RANDOMIZED, OPEN-LABEL STUDY

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 COVID-19 and will assess safety and whether the antibody treatment can reduce time to recovery. 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 placebo and two in three participants (66%) will get the investigational antibodies.

Call 1-855-282-5579

Visit c19stormchaserstudy.com

Learn More Here

CLINICAL TRIAL FOR OUTPATIENTS/EMERGENCY ROOM PATIENTS
 

C3PO (COVID-19 CONVALESCENT PLASMA CLINICAL TRIAL)
 

  • TREATMENT BEING TESTED: COVID-19 CONVALESCENT PLASMA
  • RANDOMIZED, SINGLE-BLIND, PLACEBO-CONTROLLED 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.

Visit Siren.Network

Email [email protected]

CLINICAL TRIALS FOR ADULT CONVALESCING PATIENTS

(those who have been discharged from the hospital after receiving hospital treatment for COVID-19)

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
 

  • DRUGS BEING TESTED: BLOOD THINNERS
  • RANDOMIZED, OPEN-LABEL 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.

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.

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
 

  • DRUGS BEING TESTED: IMMUNE MODULATORS + REMDESIVIR
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS

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.

Visit ACTIV-1.org

Call 877-384-6573

ACTIV-3
 

  • DRUG BEING TESTED: MONOCLONAL ANTIBODIES (additional drugs may be added later)
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS

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 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.

Call 877-414-7243

ACTIV-4
 

  • DRUGS BEING TESTED: ANTITHROMBOTICS (BLOOD THINNERS)
  • RANDOMIZED, OPEN-LABEL 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.

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.

ACTIV-5
 

  • INVESTIGATIONAL DRUG: SEVERAL DRUGS
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS

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 health care provider can:

Call 301-761-7948

Email [email protected]

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

  • TREATMENT BEING TESTED: COVID-19 CONVALESCENT PLASMA
  • RANDOMIZED, TRIPLE-BLIND, PLACEBO-CONTROLLED 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.

Visit PassItOnStudy.org

Email [email protected]

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

  • TREATMENT BEING TESTED: COVID-19 CONVALESCENT PLASMA
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 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.

Visit Med.Nyu.Edu

Email [email protected]

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

  • DRUGS BEING TESTED: BARICITINIB VS DEXAMETHASONE, BOTH WITH REMDESIVIR
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 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.

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

Call 301-761-7948

Email [email protected]

INPATIENT TREATMENT WITH ANTI-CORONAVIRUS IMMUNOGLOBULIN (ITAC)
 

  • DRUGS BEING TESTED: HYPERIMMUNE INTRAVENOUS IMMUNOGLOBULIN (HIVIG) + REMDESIVIR (VEKLURY)
  • RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 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.

Call 240-669-5328

Email [email protected]

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

  • TREATMENT BEING TESTED: SARGRAMOSTIM
  • RANDOMIZED, OPEN-LABEL STUDY

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.

Contact: [email protected]

View all NIH-funded clinical trials.

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