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Dapagliflozin 10 MGWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug1822 Placebo Wiki 0.06

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There is one clinical trial.

Clinical Trials


1 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

This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality.

NCT04350593 COVID-19 Drug: Dapagliflozin 10 MG Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Respiratory decompensation (e.g., invasive or non-invasive mechanical ventilation) New or worsening congestive HF Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest Initiation of renal replacement therapy

Measure: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following:

Time: Randomization through Day 30

Secondary Outcomes

Description: Time to death from any cause Time to new/worsened organ dysfunction (as defined in the primary outcome measure) Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7-point ordinal scale) Time to hospital discharge

Measure: Hierarchical composite outcome measures including time to death from any cause, time to new/worsened organ dysfunction, clinical status at day 30 and time to hospital discharge

Time: Randomization through Day 30

Description: Time to hospital discharge

Measure: Time to hospital discharge

Time: Randomization through Day 30

Description: Total number of days alive, out of hospital, and/or free from mechanical ventilation

Measure: Total number of days alive, out of hospital, and/or free from mechanical ventilation

Time: Randomization through Day 30

Description: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

Measure: Total number of days alive, not in the ICU, and free from mechanical ventilation (as defined in the primary outcome measure)

Time: Randomization through Day 30

Description: Time to death from any cause

Measure: Time to death from any cause

Time: Randomization through Day 30

Description: Time to new/worsened organ dysfunction

Measure: Time to new/worsened organ dysfunction

Time: Randomization through Day 30

Description: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

Measure: Time to acute kidney injury (defined as doubling of s-Creatinine compared to baseline)

Time: Randomization through Day 30


No related HPO nodes (Using clinical trials)