Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
Purpose
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).
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent - 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 - COVID-19 symptom onset ≤ 7 days prior to randomization - Oxygen saturation as measured by pulse oximetry (SpO2) > 94% on room air
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) RDV or administration of any SARS-CoV-2 (or COVID-19) vaccine - Participants 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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Remdesivir (RDV), Part A |
Participants will receive inhaled RDV 31 mg administered daily for 5 days. |
|
|
Experimental RDV + Placebo, Part A |
Participants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days. |
|
|
Placebo Comparator Placebo, Part A |
Participants will receive placebo to match inhaled RDV in Part A daily for 5 days. |
|
|
Experimental RDV, Part B |
Participants will receive inhaled RDV 62 mg administered daily for up to 5 days. |
|
|
Experimental RDV + Placebo, Part B |
Participants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days. |
|
|
Placebo Comparator Placebo, Part B |
Participants will receive placebo to match inhaled RDV in Part B daily for 5 days. |
|
|
Experimental RDV, Part C |
Participants will receive inhaled RDV 39 mg administered daily for 5 days. |
|
|
Placebo Comparator Placebo, Part C |
Participants will receive placebo to match inhaled RDV in Part C daily for 5 days. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04539262
- Status
- Completed
- Sponsor
- Gilead Sciences
Detailed Description
This study will have multiple parts: Part A, Part B, and Part C. Part B will be conducted if supported by evaluation in healthy volunteers in another Phase 1a Gilead study (GS-US-553-9018). Participants in Part C will be enrolled after review of preliminary safety and available efficacy data from Parts A and B through at least Day 7. GS-US-553-9018 is a Phase 1a randomized, blinded, placebo-controlled, single- and multiple-dose study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of remdesivir administered by inhalation.