Phase 2
N=156
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04539262 ↗Enrolled (actual)
156
Serious AEs
3.3%
Results posted
Mar 2022
Primary outcome: Primary: Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7 — -2.04; -1.51; -1.24; -1.21 log10 copies/mL — p=0.1117
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Remdesivir (RDV) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7 |
-2.04; -1.51; -1.24; -1.21; -1.42; -1.40 | 0.1117 |
| PRIMARY Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7 |
-1.10; -0.55; -1.39; -1.14; -0.85; -0.70 | 0.3417 |
| PRIMARY Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7 |
-0.80; -1.27; -0.49; -1.09; -0.61; -0.93 | 0.5951 |
| SECONDARY Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
58.3; 58.3; 41.7; 33.3; 58.3; 38.5 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade |
58.3; 91.7; 63.6; 63.6; 83.3; 61.5 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation |
0; 0; 8.3; 0; 0; 0 | — |
| SECONDARY Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28 |
1; 1; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With COVID-19 Related MAVs or Death by Day 28 |
0; 1; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Hospitalization by Day 28 |
0; 1; 1; 0; 1; 1 | — |
| SECONDARY Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B |
— | — |
| SECONDARY Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5 |
-2.44; -1.67; -1.78; -1.53; -1.68; -2.09 | — |
| SECONDARY Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5 |
-1.24; -0.88; -1.26; -1.29; -1.13; -1.10 | — |
| SECONDARY Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5 |
-0.99; -1.26; -0.77; -1.60; -0.31; -0.92 | — |
| SECONDARY Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7 |
-3.05; -2.12; -2.09; -1.80; -2.30; -2.34 | — |
| SECONDARY Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7 |
-1.76; -0.40; -1.98; -1.73; -1.08; -1.27 | — |
| SECONDARY Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7 |
-1.28; -1.24; -0.62; -1.91; -0.99; -1.53 | — |
| SECONDARY Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B |
-4.11; -2.96; -3.31; -2.82; -2.86; -3.41 | — |
| SECONDARY Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B |
-2.46; -1.47; -2.36; -1.46; -1.95; -2.05 | — |
| SECONDARY Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B |
-2.58; -2.27; -1.78; -2.30; -2.11; -3.53 | — |
| SECONDARY Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR) |
NA; 17.0; NA; 16.0; NA; NA | — |
| SECONDARY Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR) |
14.0; 15.0; 13.0; 5.0; NA; 14.0 | — |
| SECONDARY Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR) |
NA; 17.0; NA; 16.0; 14.0; NA | — |
| SECONDARY Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19 Adapted InFLUenza Patient-Reported Outcome (FLU-PRO©) Questionnaire in Part C |
NA; NA | — |
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).
Eligibility Criteria
Key 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
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) 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.
Data sourced from ClinicalTrials.gov (NCT04539262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.