Gilead Inhaled Remdesivir
Key Inclusion Criteria:
- Patients who are not hospitalized
- At least 18 years old
- SARS-CoV-2 infection first confirmed by PCR ≤4 days before assignment to treatment group
- Presence of ≥1 symptom(s) consistent with COVID-19 for ≤7 days before assignment to treatment group
- Oxygen saturation as measured by pulse oximetry (SpO2) >94% on room air
Key Exclusion Criteria:
- Prior or current hospitalization for COVID-19 or need for hospitalization
- Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2
- Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19
A Phase Ib/IIa Study in Participants with Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation (IRB no. 00001096)
The purpose of this study is to determine whether an experimental drug called remdesivir (RDV), given through inhalation, is safe and effective for the treatment of early-stage COVID-19. The study will also measure how much RDV gets into the blood and how long it takes to leave the body in individuals with COVID-19.
The study consists of multiple parts (parts A, B and C). Participants will be randomly assigned to a treatment group and will receive inhaled remdesivir or placebo (inactive substance) for 5 days. Participants in all parts of the study will have 2 out of 3 chances to receive inhaled RDV and 1 out of 3 chances to receive placebo.