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NCT04539262 · ClinicalTrials.gov registry record · Phase 1

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 1 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 1
Development phase
156
Enrollment target

NCT04539262: Completed Phase 1 study, sponsored by Gilead Sciences.

NCT04539262 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 156 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (160% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04539262, a Phase 1 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 1
Development phase
156 participants
Enrollment target

Study 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).

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Remdesivir (RDV)

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2020-09-14
Est. Completion 2021-03-22
Phase Phase 1
Gilead Sciences

504 total trials

What the finished NCT04539262 record still lists

NCT04539262 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (160% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04539262 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04539262 about?

NCT04539262 is a clinical study titled "Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation". 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).

What is the current status of trial NCT04539262?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 156 participants. The study started on 2020-09-14. Estimated completion is 2021-03-22.

What interventions are being tested in trial NCT04539262?

The interventions under investigation include: Placebo (DRUG), Remdesivir (RDV) (DRUG).

Who is sponsoring clinical trial NCT04539262?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04539262's enrollment target sits among peer trials

156 351st of 2000 higher than 1,649 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04539262, the US trial registry maintained by the National Library of Medicine. NCT04539262 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.