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Dapagliflozin in Respiratory Failure in Patients With COVID-19

NCT04350593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2022-06-10

Study results available
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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.

Conditions

Interventions

DRUG

Dapagliflozin 10 milligram (mg)

Active Comparator: Dapagliflozin 10 mg

DRUG

Placebo

Placebo Comparator

Sponsors & Collaborators

  • St. Luke's Hospital, Kansas City, Missouri

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • Saint Luke's Health System

    lead OTHER

Principal Investigators

  • Mikhail Kosiborod, MD · Saint Luke's Mid America Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2021-03-31
Completion
2021-06-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • India
  • Mexico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350593 on ClinicalTrials.gov