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WHAT IS THE STUDY ABOUT?
In prior research trials, immune modulators have helped people recover more quickly from COVID-19. The ACTIV-1 IM study is testing multiple immune modulators to answer important research questions, including:
- Which of the investigational medications will help people who are in the hospital with acute respiratory disorder due to COVID-19 feel better more quickly?
- Can these immune modulators help patients have fewer bad effects from COVID-19?
- Does this treatment help COVID-19 patients get out of the hospital faster?
If you join this study, you will receive standard of care plus either an investigational medicine or a placebo. You will also be assessed by the study team daily while you are in the hospital. If you spend fewer than 29 days in the hospital, you will have follow-up visits every few days until you have been in the study for 29 days. These follow-up visits will either be in person or by phone. There will be one final phone call assessment after you have been in the study for 60 days.
WHO CAN JOIN THIS STUDY?
If you recently tested positive and are in the hospital with COVID-19, this study may be for you. Clinical trials testing COVID-19 treatments need people from diverse backgrounds. This will help researchers find treatments that are safe and work for more people. Each person who takes part in the ACTIV-1 IM study will meet specific conditions, including:
At least 18 years
Diagnosed with COVID-19 within the past 14 days and currently in the hospital due to COVID-19
Serious respiratory distress (significant difficulty breathing and maybe requiring supplemental oxygen)
ANSWERS TO OTHER QUESTIONS YOU MIGHT HAVE
A clinical research study helps experts find treatments that are safe and effective. It is important that these studies include people from diverse backgrounds. This helps researchers develop new treatments that will work for more people.
The placebo looks like the study medication but does not have any active ingredients in it. Researchers compare how people react to both placebos and medications to learn if the medication is safe and helps people recovery more quickly. If you join this study, you will get the usual care for COVID-19.
Yes. Taking part in this clinical trial is voluntary; it is your choice. You can change your mind at any time and leave the study.