Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation

• Status: Completed
• Trial end date: 2021-03-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to characterize the impact of inhaled remdesivir (RDV) on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in participants with early stage coronavirus disease 2019 (COVID-19).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Remdesivir

Criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent

• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection first confirmed by polymerase chain reaction (PCR) (Parts A and B) or by nucleic acid testing or direct antigen testing (Part C) with sample collected ≤ 4 days prior to randomization

• Coronavirus disease 2019 (COVID-19) symptom onset ≤ 7 days prior to randomization

• Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air

Key Exclusion Criteria:

• Ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for COVID-19

• Prior or current hospitalization for COVID-19 or need for hospitalization

• Treatment of COVID-19 with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including intravenous (IV) remdesivir (RDV) or administration of any SARS-CoV-2 (or COVID-19) vaccine

• Patients chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded

• Requiring oxygen supplementation

• Positive pregnancy test

• Breastfeeding female

• Known hypersensitivity to the study treatment, its metabolites, or formulation excipient

• Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (Parts A and B only)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.