Dapagliflozin in Respiratory failure in patients with COVID-19 [COVID-19]
Research type
Research Study
Full title
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
IRAS ID
283030
Contact name
Omar Mukhtar
Contact email
Sponsor organisation
Saint Luke’s Mid America Heart Institute, Saint Luke’s Hospital of Kansas City
Eudract number
2020-001473-79
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
149478, IND
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
The study hypothesis is that treatment with dapagliflozin 10 mg daily will reduce the risk of death or disease progression in patients hospitalized with COVID-19 as compared with placebo. Recent updates on patients at risk for developing serious complications, including death, in the setting of COVID-19 indicate that those with cardiometabolic disease (cardiovascular disease, diabetes and/or kidney disease at baseline) are at much greater risk. We therefore hypothesize that immediate start of SGLT2i treatment among risk patients hospitalized with verified SARS-CoV-2 infection and that are at high risk for complications could prevent disease progression, protect key organ systems, and reduce COVID-19 complications and death.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0199
Date of REC Opinion
7 May 2020
REC opinion
Further Information Favourable Opinion