covid

Different medicines may be tested during the study at the same time.

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.

If you decide to join, you would be given information about the medicines currently being tested.

Blood Pressure

This measures how the heart is pumping and how blood is flowing through the blood vessels. The study team or nurse will wrap a cuff around your upper arm that gently squeezes it.

Blood Test

Small samples of blood will be taken to look at types of blood cells and how your body is reacting to the virus. These tests can also measure the amount of study medicine in your body and how it may be affecting the body.

Deep nose swab

This is called a “nasopharyngeal swab” or “NP swab.” The study team will insert a swab that goes deep through your nose toward the back of your throat.

Heart rate

The study team will check the rate of your heartbeat by taking your pulse at the wrist for 1 minute.

Informed consent

You will be given a document that contains all of the information about the study. Read through it and ask any questions you may have. If you agree to be in the study, you will give your permission by signing an informed consent form. Make sure you understand and agree to all parts of the study before signing. An informed consent is not a contract and you may choose to leave the study at any time.

Medical history

The study team will discuss and review your current and past health, including any medical conditions, surgeries, or medical procedures you may have had. You will also be asked if you smoke or have ever smoked before.

Monoclonal antibody

One of the medicines that 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 can help your body attack invaders, such as the virus that causes COVID-19.

Nose swab (nasal swab)

The study team will teach you how to take your own nose swab. You will be given swabs that you will put in each nostril about 1 inch deep to rotate 5 times and collect a sample.

Oxygen levels

The study team will put a small device that clips onto your finger. This device can measure the amount of oxygen in your blood and how well it is being carried from the heart through the blood to parts of your body.

Placebo

A placebo looks like the study drug but doesn’t have any actual medicine in it. This gives the study team something to compare the study medicine to.

Saliva test

You would spit into a cup to provide a saliva sample that would then be tested for the presence of the coronavirus that causes COVID-19. A saliva sample will only be collected at certain clinics, so you may or may not need to give one.

Screening

After you give your permission to be in the study by signing the informed consent form, you would answer questions about your health to make sure the study is right for you. This can happen at the clinic or over the phone. If screening is done in person, you may also have a checkup.

Side effects

These are effects from a medicine that are not expected or not wanted. They can be harmful or make you feel sick, but are not always serious. All medicines may have potential side effects. Talk to the study team for more information about any possible side effects from the medicines being tested in the study.

Antibodies

These are proteins made by the body to help protect you against germs like bacteria and viruses. COVID-19 is caused by a new virus, which means that our bodies have not yet made antibodies to fight it. People who get COVID-19 make antibodies that may protect them against COVID-19 in the future.

Contagious

A disease is called contagious when it spreads from one person to another. It can spread by touching the person who has the disease, by touching an object that has been contaminated, or by breathing in droplets when a person with the disease coughs, sneezes, or talks.

Coronavirus

This is the type of virus that causes COVID-19. The full name of the virus is called SARS-CoV-2, or “severe acute respiratory syndrome coronavirus 2.” This is a new virus that no one in the world has ever come across before.

COVID-19

COVID-19 stands for “coronavirus disease 2019.” It’s caused by a new type of virus that mainly affects the lungs and is making people sick all over the world.

Immunity

A person has immunity when the body has protection from a disease because it is able to fight it off without getting sick. Herd immunity happens when enough people have immunity to a virus so that the virus can no longer quickly spread and cause disease.

Incubation period

Incubation period is the time from when you were exposed to the virus to the time you start to notice symptoms. During the incubation period, most people don’t even know they are carrying the virus.

Pandemic

Pandemic occurs when a disease for which people have no immunity (protection) has spread to different countries all over the world.

Pneumonia

Pneumonia is an infection in one or both lungs that some people with COVID-19 can get. It can be mild or so severe that you need to be in the hospital. Pneumonia can cause a fever, cough, trouble breathing, chest pains, and tiredness.

Quarantine

Quarantine means separating someone who has probably been exposed to a disease from others. This helps to keep people who may have the disease away from people who do not have the disease.

Shortness of breath

Shortness of breath is a feeling that you can’t get enough air. You may feel out of breath or have a tightness in your chest.

Social distancing

Social distancing can help to slow the spread of disease. It means avoiding large groups and public gatherings and staying about 6 feet away from others when possible.

Symptoms

Symptoms are what you may feel if you have a disease or other health problem. The most common symptoms of COVID-19 are a high fever and a new cough that happens all the time. Other common symptoms include tiredness, muscle aches, headache, and shortness of breath. Those with a more serious infection may develop pneumonia.

Vaccines

Vaccines are the most effective way to prevent contagious diseases from spreading. They contain a tiny part of killed or weak germs to train your body on how to fight the germs if they ever try to enter your body in the future.

Ventilator

Ventilator is a machine that helps people breathe when they can’t breathe well enough on their own. Some people who have severe symptoms of COVID-19 may have to use one.

Viruses

Viruses are tiny germs that cause diseases like the common cold and the flu. They need living things to live and spread. Viral infection happens when the virus takes over cells in your body and makes you sick.

What is COVID-19?

COVID-19 is the sickness caused by a new coronavirus called SARS-CoV-2 which has spread all over the world. It can cause serious problems like pneumonia (an inflammation of the lungs) in some people. This can result in hospitalization and can be life-threatening. Click here for more information on COVID-19.

Are there any treatments for COVID-19?

Because COVID-19 is a new disease, right now there are no specific treatments or vaccines. Researchers believe there are some medicines that may help, but they need to first be tested in a clinical study.

What is the ACTIV-2 Study testing?

The ACTIV-2 Study is testing several different medicines to see if they are safe and can help adults with COVID-19 get better. Researchers also want to know if the medicines can stop the disease from getting worse so that people don’t have to go to the hospital.

Who can be in the ACTIV-2 Study?

The study is for adults 18 years and older who have tested positive for COVID-19 within the last 7 days (within one week of having the test) and are at home with symptoms (fever, cough, trouble breathing or feeling "out of breath," sore throat, body pain or muscle aches, tiredness, headache, chills, stuffy or runny nose, loss of taste or smell, nausea or throwing up, diarrhea).

What study medicine would I get if I joined the study?

The study is testing many different investigational medicines for COVID-19. Each medicine will be compared to a placebo. A placebo looks like the real drug, but doesn't have any actual medicine in it. You would be placed in a group by chance to receive either one of these medicines or a placebo. You won't know what group you are in until the end of the study. Click here for more information on treatment.

Do I have to join the study?

Being in the study is voluntary and you do not have to join. If you decide to join and then change your mind, you can leave the study at any time.

How long would I be in the study?

You would be in the study for about 6 months (24 weeks).

How many study visits would I have?

The number of study visits and tests you have will depend on whether you are in Phase 2 or Phase 3 of the study. You may have up to 7 visits for tests and up to 5 phone calls with the study team. Click here for more information on the study visit schedule.

What are the possible risks of being in the study?

Being in any clinical study may have some risks. There is a chance that the study medicine may cause side effects. There is a chance that the medicine may not work and may not make you feel better or stop you from getting sicker. Also, not everyone will receive the study medicine, some people may receive the placebo.

What are the possible benefits from being in the study?

The benefits of the study medicine are not known, but there is a chance that it may work and make you feel better or stop you from getting sicker. Even if you do not directly benefit from the study medicine, information learned from this study may help others who have COVID-19.

Would being in the study cost me money?

You do not have to pay for study visits or tests. Check with your insurance company to see if they would pay for medical care related to the study medicine if needed. Costs related to hospital stays will not be covered by the study.

Would I be in Phase 2 or Phase 3 of the study?

When you consent to join the study, you would be told which phase you would join, either Phase 2 or Phase 3. Click here for more information on Phase 2 and Phase 3 of the ACTIV-2 Study.

Will I receive any reimbursement if I join the study?

Yes, you will be reimbursed for your time and contributions. The amount varies by location. There may also be support for travel to study visits. The study coordinator will discuss reimbursement with you.

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