Trial · NCT04350593
Dapagliflozin in Respiratory Failure in Patients With COVID-19
NCT04350593, Phase 3, Completed, Saint Luke's Health System; results first posted 2022-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dapagliflozin in Respiratory Failure in Patients With COVID-19. Trials, record NCT04350593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04350593
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dapagliflozin in Respiratory Failure in Patients With COVID-19
- NCT number
- NCT04350593
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- Saint Luke's Health System
- Conditions
- COVID-19
- Interventions
- Dapagliflozin 10 milligram (mg), Placebo
- First posted
- 2020-04-17
- Last updated
- 2022-06-10
- Results first posted
- 2022-04-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Randomization through Day 30 | Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. New/worsened organ dysfunction is defined as at least one of the following: * Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP), and/or initiation of extracorporeal membrane oxygenation (ECMO) * New or worsening congestive heart failure * 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 * Doubling of s-Creatinine or initiation of renal replacement therapy |
| Primary | Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. | Randomization through Day 30 | The number of patients experiencing improvement by day 30 compared with baseline (discharged from hospital without a worsening event and alive, or still in hospital without a worsening event and without oxygen support) in the hierarchical composite endpoint analysis. Hierarchical composite outcome measure includes: * Death from any cause through Day 30 * New/worsened organ dysfunction * Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction * Hospital discharge before Day 30 and alive at Day 30 |
| Secondary | Time to Hospital Discharge | Randomization through Day 30 | Time to hospital discharge (refers to index hospitalization only). Median time to hospital discharge is presented in days. |
| Secondary | Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Randomization through Day 30 | Total number of days alive and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in hospital with mechanical ventilation and days dead. |
| Secondary | Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Randomization through Day 30 | Total number of days alive, not in the ICU and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in ICU and days dead. |
| Secondary | Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause | Randomization through Day 30 | Acute kidney injury is defined as an episode of doubling s-creatinine compared to baseline during index hospitalization or SAE. Initiation of renal replacement therapy is defined as initiation of renal replacement therapy during index hospitalization or SAE. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. |
| Secondary | Time to Death From Any Cause | Randomization through Day 30 | Time to death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Randomization through Day 30 | Patients with events/100 pt-mos at risk | NUMBER | |
| PRIMARY | Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. | Randomization through Day 30 | participants | NUMBER | |
| SECONDARY | Time to Hospital Discharge | Randomization through Day 30 | days | MEDIAN | |
| SECONDARY | Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Randomization through Day 30 | days | MEAN | |
| SECONDARY | Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Randomization through Day 30 | days | MEAN | |
| SECONDARY | Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause | Randomization through Day 30 | Patients with events/100 pt-mos at risk | NUMBER | |
| SECONDARY | Time to Death From Any Cause | Randomization through Day 30 | Patients with events/100 pt-mos at risk | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Dapagliflozin 10mg | 12.4 | Patients with events/100 pt-mos at risk | ||
| 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. | Placebo | 15.6 | Patients with events/100 pt-mos at risk | ||
Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. | Dapagliflozin 10mg | 547 | participants | ||
Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. | Placebo | 532 | participants | ||
| Time to Hospital Discharge | Dapagliflozin 10mg | 5 | 95% Confidence Interval 5.0 to 6.0 | days | |
| Time to Hospital Discharge | Placebo | 6 | 95% Confidence Interval 5.0 to 6.0 | days | |
| Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Dapagliflozin 10mg | 27.8 | Standard Deviation 6.8 | days | |
| Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Placebo | 27.4 | Standard Deviation 7.4 | days | |
| Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Dapagliflozin 10mg | 27.5 | Standard Deviation 7.2 | days | |
| Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP) | Placebo | 27.1 | Standard Deviation 7.7 | days |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapagliflozin 10mg | 625 | |
| Overall Study | STARTED | Placebo | 625 | |
| Overall Study | COMPLETED | Dapagliflozin 10mg | 617 | |
| Overall Study | COMPLETED | Placebo | 620 | |
| Overall Study | NOT COMPLETED | Dapagliflozin 10mg | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute Kidney Injury | Renal and urinary disorders | Dapagliflozin 10mg | 2 | 613 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Placebo | 2 | 616 | |
| serious | COVID-19 | Infections and infestations | Dapagliflozin 10mg | 5 | 613 | |
| serious | COVID-19 | Infections and infestations | Placebo | 3 | 616 | |
| serious | Septic Shock | Infections and infestations | Dapagliflozin 10mg | 5 | 613 | |
| serious | Septic Shock | Infections and infestations | Placebo | 6 | 616 | |
| serious | Severe acute respiratory syndrome | Infections and infestations | Dapagliflozin 10mg | 3 | 613 | |
| serious | Severe acute respiratory syndrome | Infections and infestations | Placebo | 3 | 616 | |
| serious | COVID-19 pneumonia | Infections and infestations | Dapagliflozin 10mg | 1 | 613 | |
| serious | COVID-19 pneumonia | Infections and infestations | Placebo | 4 | 616 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapagliflozin 10mg | 41 | 625 |
| Total, all-cause mortality | Placebo | 54 | 625 |
| Total, other adverse events | Dapagliflozin 10mg | 2 | 613 |
| Total, other adverse events | Placebo | 2 | 616 |
| Total, serious adverse events | Dapagliflozin 10mg | 70 | 613 |
| Total, serious adverse events | Placebo | 87 | 616 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Dapagliflozin 10mg vs Placebo: Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30. | Trial comparisons |
| Dapagliflozin 10mg vs Placebo: deaths from any cause | Trial comparisons |
| Dapagliflozin 10mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04350593
GET https://conductscience.org/api/trials/v1/NCT04350593/events?page=2