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NCT04350593 · ClinicalTrials.gov registry record · Phase 3
Dapagliflozin in Respiratory Failure in Patients With COVID-19
A Phase 3 study, sponsored by Saint Luke's Health System.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,250
- Enrollment target
NCT04350593: Completed Phase 3 study, sponsored by Saint Luke's Health System.
NCT04350593 is a Phase 3 study that has completed, run by Saint Luke's Health System. The registered enrollment target is 1,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04350593, a Phase 3 study, has completed, sponsored by Saint Luke's Health System.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,250 participants
- Enrollment target
Study Summary
This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of dapagliflozin 10 milligrams versus placebo, given once daily for 30 days in addition to background local standard of care therapy, on reducing complications and all-cause mortality, or improving clinical recovery.
Primary Outcome
Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. New/worsened organ dysfunction is defined as at least one of the following: * Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilat
Interventions
- DRUG Placebo
- DRUG Dapagliflozin 10 milligram (mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2020-04-22 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 3 |
What the finished NCT04350593 record still lists
NCT04350593 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04350593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04350593 about?
NCT04350593 is a clinical study titled "Dapagliflozin in Respiratory Failure in Patients With COVID-19". This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of...
What is the current status of trial NCT04350593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2020-04-22. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT04350593?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin 10 milligram (mg) (DRUG).
Who is sponsoring clinical trial NCT04350593?
This trial is sponsored by Saint Luke's Health System, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04350593's enrollment target sits among peer trials
1,250 207th of 2000 higher than 1,791 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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