In general, what is the purpose of the research, how long will you be involved?

You are being invited to participate in ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications. About 15,000 participants from around 280 sites across the United States will be involved. The study is funded by The National Center for Advancing Translational Sciences (NCATS), a division of The National Institutes of Health (NIH). Duke Clinical Research Institute (DCRI) is the clinical coordinating center and Vanderbilt University Medical Center (VUMC) is the data coordinating center for this study. Please consider the following information in making your decision.

You are being asked to participate in this study because you have been diagnosed with the SARS-CoV-2 virus, you currently have some symptoms of COVID-19, the disease caused by the virus, and you are at least 30 years old. As part of this study, you will be given either a study medication or a placebo to see what types of effects the study medication or the placebo may have on your ability to get better and recover from the infection. You may benefit, but there is no guarantee. Others may benefit from the information learned.

Inclusion:

• You are at least 30 years old.
• You have the results of a SARS-CoV-2 test (COVID-19test) dated within the last 10 days for infection or reinfection.
• You have at least two of the following symptoms of acute infection for less than or equal to 7 days: fatigue, dyspnea (shortness of breath), fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell.

Exclusion:

• Current or recent (within 10 days of screening) hospitalization for COVID-19 infection.
• Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI)
• Current or recent use (within the last 14 days) of study drug or study drug/device combination.
• Previously enrolled in the ACTIV-6 trial.