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

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).

Timeline

Start

2020-09-14

Primary completion

2021-02-26

Completion

2021-03-22

Outcome

Missed primary endpoint

registry analysis (superiority test); RDV, Part A vs Placebo, Part A; p = 0.1117; NCT04539262 ↗

registry analysis (superiority test); RDV, Part A vs Placebo, Part A; p = 0.3417; NCT04539262 ↗

registry analysis (superiority test); RDV, Part A vs Placebo, Part A; p = 0.5951; NCT04539262 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Remdesivir	Small molecule	31 mg	Inhaled
Subject	Remdesivir	Small molecule	39 mg	Inhaled
Subject	Remdesivir	Small molecule	62 mg	Inhaled

Indications