Dapagliflozin in Respiratory Failure in Patients With COVID-19

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
Saint Luke's Health System
Study ID
NCT04350593
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 22, 2020
Status verified
May 2022
Primary completion
Mar 31, 2021
Completion
Jun 11, 2021

Study Design

Enrollment
1,250 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin 10mg
    Dapagliflozin 10 mg daily
  • Placebo Comparator: Placebo
    Dapagliflozin matching placebo 10 mg daily

Primary Outcome Measure

Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause. [ Time Frame: Randomization through Day 30 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Heart Group of the Eastern ShoreFairhopeAlabama36532-
Baptist Hospital of MiamiMiamiFlorida33176-
NorthShore University HealthSystemEvanstonIllinois60201-
Loyola UniversityMaywoodIllinois60153-
Ascension - St. VincentIndianapolisIndiana46260-
Lahey HealthBurlingtonMassachusetts01805-
McLaren Health CareAuburn HillsMichigan48326-
University of Mississippi Medical CenterJacksonMississippi39216-
Saint Luke's Mid America Heart InstituteKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
Maimonides Medical CenterBrooklynNew York11219-
SUNY Downstate Medical CenterBrooklynNew York11203-
St. Francis HospitalRoslynNew York11576-
Jacobi Medical CenterThe BronxNew York10461-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
Lancaster General HospitalLancasterPennsylvania17604-
Rhode Island HospitalProvidenceRhode Island02903-
Clinical Trials Network of TennesseeMemphisTennessee38103-
DHR Health Institute for Research and DevelopmentEdinburgTexas78539-
Baylor College of MedicineHoustonTexas77030-
Sentara HealthcareNorfolkVirginia23507-

Find similar trials in Fairhope, AL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Heart Group of the Eastern Shore· Fairhope, ALBaptist Hospital of Miami· Miami, FLNorthShore University HealthSystem· Evanston, ILLoyola University· Maywood, ILAscension - St. Vincent· Indianapolis, INLahey Health· Burlington, MA

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