A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Subsequent Vaccine

COVID-19 and Mpox

Right now there is no medicine proven to treat COVID-19 in people who are not sick enough to be hospitalized. Researchers will be testing different investigational medicines that they believe are most likely to help people with COVID-19.

They want to see if these investigational medicines:

• Are safe for those who need them
• Can help people get better faster
• Can get rid of the virus
• Can help keep oxygen levels up
• Can keep people from getting sicker
• Can prevent people from having to go to the hospital

The whole study lasts about 6 months (24 weeks).

During the study you would have in-person visits with tests to check on your health. Most of these visits happen during the first month of the study.

You would also have phone calls or videos chats with the researcher from your home.

The study team will give you a diary to keep track of your temperature each evening and any symptoms you have. You’ll be asked to fill out this diary for the first 28 days.

If the study is right for you, you will have your first visit, or entry visit, to meet with a researcher for tests and to be placed in a treatment group.

Each study medicine will be compared to a placebo. A placebo looks like the real drug but doesn’t have any actual medicine in it. This gives researchers something to compare the study medicine to. You would not know if you are receiving the study medicine or placebo until the end of the study. If a standard treatment for COVID-19 is found during the study, that treatment will be used instead of placebo. Different medicines may be tested during the study at the same time. One type of investigational medicine you might receive is called a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the lab and help your body attack invaders, such as viruses, to keep them from entering your cells. Once you are placed in a treatment group, you will receive more information on that investigational medicine being tested, including any possible side effects.

 

To learn more about this study click here.