Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
12–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.
* Stuffy or runny nose.
* Sore throat.
* Shortness of breath (difficulty breathing).
* Cough.
* Low energy or tiredness.
* Muscle or body aches.
* Headache.
* Chills or shivering.
* Feeling hot or feverish.
Not currently hospitalized or requiring hospitalization.
You may not be if
Any risk factors for progression to severe disease.
Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
Received an COVID-19 vaccine (including booster dose) \< 120 days before randomization.
Self-reported COVID-19 diagnosis \< 120 days before randomization.
Anticipated need for hospitalization \< 48 hours after randomization.
New oxygen requirement \< 24 hours before randomization.
Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
Undergoing dialysis, or known history of chronic kidney disease.
Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
Pregnant or breastfeeding.
Unwilling to use protocol-mandated contraception.
Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
Concurrent participation/enrollment in a separate therapeutic clinical study.
