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NCT04341675 · ClinicalTrials.gov registry record · Phase 2
Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia
A Phase 2 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT04341675: Completed Phase 2 study, sponsored by University of Cincinnati.
NCT04341675 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04341675, a Phase 2 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.
Primary Outcome
Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP\* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. \* CPAP use for known obstructive sleep apnea will not be considered as disease progression.
Interventions
- DRUG Sirolimus
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2020-09-15 |
| Phase | Phase 2 |
What the finished NCT04341675 record still lists
NCT04341675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT04341675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04341675 about?
NCT04341675 is a clinical study titled "Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia". The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolim...
What is the current status of trial NCT04341675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2020-04-24. Estimated completion is 2020-09-15.
What interventions are being tested in trial NCT04341675?
The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG).
Who is sponsoring clinical trial NCT04341675?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04341675's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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