CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,250 enrolled
Drug / intervention
Dapagliflozin 10 milligram (mg) +1 moredrug
Likely dose
Dapagliflozin 10 milligram (mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04350593
NCT04350593Phase 3Completed

An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients With COVID-19

Saint Luke's Health System·interventional·Posted Apr 17, 2020·Updated Jun 10, 2022

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin 10 milligram (mg) and Placebo for COVID-19. Completed, enrolled 1,250 participants across 95 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesArgentina, Brazil, Canada, India, Mexico, United Kingdom, United States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 17, 2020
Enrollment StartApr 22, 2020
Primary CompletionMar 31, 2021
Study CompletionJun 11, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.2 years ago

Interventions

Dapagliflozin 10 milligram (mg)drug

Active Comparator: Dapagliflozin 10 mg

Placebodrug

Placebo Comparator