Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
A Phase 1b/2a Study in Participants With Early Stage COVID-19 to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
1 other identifier
interventional
156
1 country
28
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Sep 2020
Shorter than P25 for phase_1 covid19
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2021
CompletedResults Posted
Study results publicly available
March 3, 2022
CompletedMarch 3, 2022
February 1, 2022
6 months
August 26, 2020
February 18, 2022
February 18, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as area under the concentration versus time curve (AUC) of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7
Time-weighted average change in SARS-CoV-2 viral load was defined as AUC of viral load change divided by time between baseline through Day 7.
Baseline, Day 7
Secondary Outcomes (31)
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade
First dose date up to 5 days plus 30 days
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
First dose date up to 5 days plus 30 days
Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28
Randomization up to Day 28
Number of Participants With COVID-19 Related MAVs or Death by Day 28
Randomization up to Day 28
- +26 more secondary outcomes
Study Arms (8)
Remdesivir (RDV), Part A
EXPERIMENTALParticipants will receive inhaled RDV 31 mg administered daily for 5 days.
RDV + Placebo, Part A
EXPERIMENTALParticipants will receive inhaled RDV 31 mg administered daily for 3 days followed by placebo to match RDV daily for 2 days.
Placebo, Part A
PLACEBO COMPARATORParticipants will receive placebo to match inhaled RDV in Part A daily for 5 days.
RDV, Part B
EXPERIMENTALParticipants will receive inhaled RDV 62 mg administered daily for up to 5 days.
RDV + Placebo, Part B
EXPERIMENTALParticipants will receive inhaled RDV 62 mg administered daily for up to 3 days followed by placebo to match RDV daily for 2 days.
Placebo, Part B
PLACEBO COMPARATORParticipants will receive placebo to match inhaled RDV in Part B daily for 5 days.
RDV, Part C
EXPERIMENTALParticipants will receive inhaled RDV 39 mg administered daily for 5 days.
Placebo, Part C
PLACEBO COMPARATORParticipants will receive placebo to match inhaled RDV in Part C daily for 5 days.
Interventions
Administered as an aerosolized solution
Administered as an aerosolized solution
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (28)
The Institute for Liver Health
Mesa, Arizona, 85210, United States
The Institute for Liver Health
Tucson, Arizona, 85712, United States
Franco Felizarta, MD
Bakersfield, California, 93301, United States
Aurora FDRC Inc.
Costa Mesa, California, 92627, United States
Elevated Health
Huntington Beach, California, 92648, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Western Clinical Research
Placentia, California, 92870, United States
UC Davis Health/Medical Center
Sacramento, California, 95817, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Research in Miami, Inc.
Hialeah, Florida, 33013, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, 33016, United States
Optimus U Corporation
Miami, Florida, 33125, United States
L & C Professional Medical Research Institute
Miami, Florida, 33144, United States
Westchester Research Center at Westchester General Hospital
Miami, Florida, 33155, United States
MedBio Trials
Miami, Florida, 33180, United States
Nuovida Research Center, Corp
Miami, Florida, 33186, United States
IMIC Inc
Palmetto Bay, Florida, 33157, United States
Triple O Research Institute, PA
West Palm Beach, Florida, 33401, United States
Family Care Research
Boise, Idaho, 83704, United States
CTU Covid Research Center
New Orleans, Louisiana, 70112, United States
STAT Research
Vandalia, Ohio, 45066, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
DFW Clinical Research
Dallas, Texas, 75234, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
PCP for Life-Tidwell
Houston, Texas, 77093, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
September 4, 2020
Study Start
September 14, 2020
Primary Completion
February 26, 2021
Study Completion
March 22, 2021
Last Updated
March 3, 2022
Results First Posted
March 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share