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Dapagliflozin in Respiratory Failure in Patients With COVID-19 (DARE-19)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin 10 milligram (mg)
Placebo
Sponsored by
Saint Luke's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring sodium-glucose cotransporter-2 inhibitor (SGLT2i), dapagliflozin, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of informed consent
  2. Male or female patients aged ≥18 years
  3. Currently hospitalized
  4. Hospital admission no more than 4 days prior to screening
  5. Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation
  6. Chest radiography or computerized tomography (CT) findings that, in the opinion of the investigator, are consistent with coronavirus disease 2019 (COVID-19)
  7. Blood oxygen saturation (SpO2) ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less)

  8. Medical history of at least one of the following:

    1. hypertension
    2. type 2 diabetes
    3. atherosclerotic cardiovascular disease
    4. heart failure (with either reduced or preserved left ventricular ejection fraction (LVEF))
    5. chronic kidney disease stage 3 to 4 (estimated glomerular filtration rate (eGFR) between 25 to 60 mL/min/1.73 m2)

Key Exclusion Criteria:

  1. Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP))
  2. Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours
  3. Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator
  4. eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis
  5. Systolic blood pressure <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening
  6. History of type 1 diabetes mellitus
  7. History of diabetic ketoacidosis
  8. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19
  9. Current treatment with any sodium-glucose cotransporter-2 inhibitor (SGLT2i) (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening

  10. Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry

    • Note that use of rescue therapies including immune modulators, monoclonal antibody therapies, antiviral therapies, and other agents that are approved or being used through open-label compassionate/expanded use programs or in accordance with the local standard of care is permitted during the study.

Sites / Locations

  • Heart Group of the Eastern Shore
  • Baptist Hospital of Miami
  • NorthShore University HealthSystem
  • Loyola University
  • Ascension - St. Vincent
  • Lahey Health
  • McLaren Health Care
  • University of Mississippi Medical Center
  • Saint Luke's Mid America Heart Institute
  • Washington University School of Medicine
  • Jacobi Medical Center
  • SUNY Downstate Medical Center
  • Maimonides Medical Center
  • St. Francis Hospital
  • University of North Carolina at Chapel Hill
  • Wake Forest Baptist Health
  • Lancaster General Hospital
  • Rhode Island Hospital
  • Clinical Trials Network of Tennessee
  • DHR Health Institute for Research and Development
  • Baylor College of Medicine
  • Sentara Healthcare
  • Clínica de Especialidades Villa María
  • Fundación Favaloro
  • Hospital Español
  • Hospital Fernández
  • Hospital Pirovano
  • Hospital Santojanni
  • Sanatorio Anchorena
  • Sanatorio Güemes
  • Clínica Vélez Sarsfield
  • Hospital San Roque
  • Sanatorio Privado Duarte Quiros de Clinica Colombo S.A.
  • Centro de Pesquisa Dr. Marco Mota
  • Hospital EMEC e Hospital da Cidade
  • Hospital e Clínica São Roque
  • Hospital Regional Deputado Luis Eduardo Magalhães
  • Hospital Cárdio Pulmonar
  • Hospital Maternidade São Vicente de Paulo
  • Unimed de Fortaleza
  • Hospital de Messejana Dr Carlos Alberto Studart Gomes
  • Hospital Coração do Brasil
  • Hospital Estadual Jayme dos Santos Neves
  • Liga de Hipertensão Arterial
  • Santa Casa de Misericórdia de Passos
  • Hospital São Domingos - Unimed Uberaba
  • PROCAPE
  • Hospital Giselda Trigueiro
  • Associação Dr. Bartholomeu Tacchini
  • Hospital São Vicente de Paulo
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Hospital Mãe de Deus
  • Hospital São José - Criciúma
  • IPEMI- Instituto de Pesquisas Médicas de Itajaí
  • Hospital Municipal São José
  • Hospital Regional Hans Dieter Schmidt
  • Centro de Pesquisa Clínica do Coração
  • Faculdade de Medicina de Botucatu, UNESP
  • Instituto de Pesquisa Clínica de Campinas
  • Unimed Ribeirao Preto
  • Fundação do ABC (Hospital Estadual Mário Covas)
  • Centro Integrado de Pesquisas
  • Santa Casa de Votuporanga
  • Fundação Pio XII
  • Hospital Naval Marcílio Dias
  • Hospital Moriah
  • Hospital Santa Paula
  • InCor - Instituto do Coração do Hospital das Clínicas FMUSP
  • Halton Healthcare Services
  • Lakeridge Health
  • CIMS Hospital Pvt. Ltd
  • MIOT International Hospitals
  • All India Institute of Medical Science
  • Sanjivani Super Speciality Hospital Pvt Ltd
  • Lokmanya Tilak General Hospital
  • Max Smart Super Speciality Hospital
  • Max Super Speciality Hospital (A unit of Devki Devi Foundation)
  • Dayanand Medical College & Hospital
  • Hospital del Prado
  • Icaro Investigaciones en Medicina
  • HG de Cuernavaca Dr. Jose G Parres
  • JM Research
  • Instituto de Investigaciones Aplicadas a la Neurosciencias
  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcade"
  • Hospital San Javier
  • Invesclinic MX
  • CIMEZAP
  • Hospital Medica Sur
  • Hospital Clinica Nova
  • Hospital San Jose TEC Salud
  • ECI Estudios Clinicos Internacionales
  • Hospital SMIQ
  • Investigacion Medica Sonora
  • Sanatorio Santa Cruz de Toluca
  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapagliflozin 10mg

Placebo

Arm Description

Dapagliflozin 10 mg daily

Dapagliflozin matching placebo 10 mg daily

Outcomes

Primary Outcome Measures

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 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
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.
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 Outcome Measures

Time to Hospital Discharge
Time to hospital discharge (refers to index hospitalization only). Median time to hospital discharge is presented in 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)
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.
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)
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.
Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause
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.
Time to Death From Any Cause
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.

Full Information

First Posted
April 14, 2020
Last Updated
May 13, 2022
Sponsor
Saint Luke's Health System
Collaborators
Saint Luke's Hospital of Kansas City, AstraZeneca, George Clinical Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04350593
Brief Title
Dapagliflozin in Respiratory Failure in Patients With COVID-19
Acronym
DARE-19
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System
Collaborators
Saint Luke's Hospital of Kansas City, AstraZeneca, George Clinical Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
COVID-19 can lead to multiorgan failure, especially in high-risk patients. Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), favorably impacts many processes dysregulated during acute illness such as COVID-19, has significant cardio- and reno-protective benefits in cardiometabolic disease, and may provide similar organ protection in COVID-19. The study population will include hospitalized patients with respiratory manifestations of COVID-19 of any duration, but without the need for mechanical ventilation. The eligible patients should have risk factors for developing serious complications of COVID-19, including hypertension, Type 2 diabetes, atherosclerotic cardiovascular disease, heart failure and/or chronic kidney disease stage 3 to 4. Patients will be treated for 30 days, with either dapagliflozin 10 milligrams daily or placebo, each to be given in addition to the usual standard of care in the participating hospital. The study assessments include only those that are absolutely critical for ensuring the safety of the patients, to measure efficacy outcomes, and collect biomarker data, so as not to place too high a burden on the study personnel and to minimize additional risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The dual primary efficacy endpoints of the study are time to first event of either complications or death from any cause, and improved clinical recovery through 30 days of follow-up. An extended follow-up period of 60 days (after the 30-day treatment period) is included, in order to examine longer-term trajectory of recovery from COVID-19 among trial participants. The safety data will be monitored by an Independent Data and Safety Monitoring Committee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
sodium-glucose cotransporter-2 inhibitor (SGLT2i), dapagliflozin, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin 10mg
Arm Type
Active Comparator
Arm Description
Dapagliflozin 10 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dapagliflozin matching placebo 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 milligram (mg)
Other Intervention Name(s)
Farxiga
Intervention Description
Active Comparator: Dapagliflozin 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Randomization through Day 30
Title
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.
Description
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
Time Frame
Randomization through Day 30
Secondary Outcome Measure Information:
Title
Time to Hospital Discharge
Description
Time to hospital discharge (refers to index hospitalization only). Median time to hospital discharge is presented in days.
Time Frame
Randomization through Day 30
Title
Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
Description
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.
Time Frame
Randomization through Day 30
Title
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)
Description
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.
Time Frame
Randomization through Day 30
Title
Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause
Description
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.
Time Frame
Randomization through Day 30
Title
Time to Death From Any Cause
Description
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.
Time Frame
Randomization through Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent Male or female patients aged ≥18 years Currently hospitalized Hospital admission no more than 4 days prior to screening Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation Chest radiography or computerized tomography (CT) findings that, in the opinion of the investigator, are consistent with coronavirus disease 2019 (COVID-19) Blood oxygen saturation (SpO2) ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less) Medical history of at least one of the following: hypertension type 2 diabetes atherosclerotic cardiovascular disease heart failure (with either reduced or preserved left ventricular ejection fraction (LVEF)) chronic kidney disease stage 3 to 4 (estimated glomerular filtration rate (eGFR) between 25 to 60 mL/min/1.73 m2) Key Exclusion Criteria: Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP)) Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis Systolic blood pressure <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening History of type 1 diabetes mellitus History of diabetic ketoacidosis Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19 Current treatment with any sodium-glucose cotransporter-2 inhibitor (SGLT2i) (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry Note that use of rescue therapies including immune modulators, monoclonal antibody therapies, antiviral therapies, and other agents that are approved or being used through open-label compassionate/expanded use programs or in accordance with the local standard of care is permitted during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Kosiborod, MD
Organizational Affiliation
Saint Luke's Mid America Heart Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Group of the Eastern Shore
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Ascension - St. Vincent
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Lahey Health
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
McLaren Health Care
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Luke's Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Clinical Trials Network of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
DHR Health Institute for Research and Development
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Healthcare
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Clínica de Especialidades Villa María
City
Villa María
State/Province
Province Of Córdoba
Country
Argentina
Facility Name
Fundación Favaloro
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Español
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Fernández
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Pirovano
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Santojanni
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Anchorena
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Güemes
City
Buenos Aires
Country
Argentina
Facility Name
Clínica Vélez Sarsfield
City
Córdoba
Country
Argentina
Facility Name
Hospital San Roque
City
Córdoba
Country
Argentina
Facility Name
Sanatorio Privado Duarte Quiros de Clinica Colombo S.A.
City
Córdoba
Country
Argentina
Facility Name
Centro de Pesquisa Dr. Marco Mota
City
Maceió
State/Province
Alagoas
ZIP/Postal Code
57051-160
Country
Brazil
Facility Name
Hospital EMEC e Hospital da Cidade
City
Feira de Santana
State/Province
Bahia
ZIP/Postal Code
44035-010
Country
Brazil
Facility Name
Hospital e Clínica São Roque
City
Ipiaú
State/Province
Bahia
ZIP/Postal Code
45570-000
Country
Brazil
Facility Name
Hospital Regional Deputado Luis Eduardo Magalhães
City
Porto Seguro
State/Province
Bahia
ZIP/Postal Code
45810-000
Country
Brazil
Facility Name
Hospital Cárdio Pulmonar
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-275
Country
Brazil
Facility Name
Hospital Maternidade São Vicente de Paulo
City
Barbalha
State/Province
Ceará
ZIP/Postal Code
63180-000
Country
Brazil
Facility Name
Unimed de Fortaleza
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60055-172
Country
Brazil
Facility Name
Hospital de Messejana Dr Carlos Alberto Studart Gomes
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Hospital Coração do Brasil
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70390-700
Country
Brazil
Facility Name
Hospital Estadual Jayme dos Santos Neves
City
Serra
State/Province
Espírito Santo
ZIP/Postal Code
29166-828
Country
Brazil
Facility Name
Liga de Hipertensão Arterial
City
Goiania
State/Province
Goias
ZIP/Postal Code
74690-900
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Passos
City
Passos
State/Province
Minas Gerais
ZIP/Postal Code
37904-020
Country
Brazil
Facility Name
Hospital São Domingos - Unimed Uberaba
City
Uberaba
State/Province
Minas Gerais
ZIP/Postal Code
38025-440
Country
Brazil
Facility Name
PROCAPE
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50100-060
Country
Brazil
Facility Name
Hospital Giselda Trigueiro
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59037-170
Country
Brazil
Facility Name
Associação Dr. Bartholomeu Tacchini
City
Bento Gonçalves
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95700-084
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Hospital São José - Criciúma
City
Criciuma
State/Province
Santa Catarina
ZIP/Postal Code
88811-250
Country
Brazil
Facility Name
IPEMI- Instituto de Pesquisas Médicas de Itajaí
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-303
Country
Brazil
Facility Name
Hospital Municipal São José
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
74605-050
Country
Brazil
Facility Name
Hospital Regional Hans Dieter Schmidt
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89228-025
Country
Brazil
Facility Name
Centro de Pesquisa Clínica do Coração
City
Aracaju
State/Province
Sergipe
ZIP/Postal Code
49055-530
Country
Brazil
Facility Name
Faculdade de Medicina de Botucatu, UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Facility Name
Instituto de Pesquisa Clínica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Unimed Ribeirao Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14110-000
Country
Brazil
Facility Name
Fundação do ABC (Hospital Estadual Mário Covas)
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09090-790
Country
Brazil
Facility Name
Centro Integrado de Pesquisas
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Santa Casa de Votuporanga
City
Votuporanga
State/Province
São Paulo
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Fundação Pio XII
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Naval Marcílio Dias
City
Rio de Janeiro
ZIP/Postal Code
20725-090
Country
Brazil
Facility Name
Hospital Moriah
City
São Paulo
ZIP/Postal Code
04083-002
Country
Brazil
Facility Name
Hospital Santa Paula
City
São Paulo
ZIP/Postal Code
04556-100
Country
Brazil
Facility Name
InCor - Instituto do Coração do Hospital das Clínicas FMUSP
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Halton Healthcare Services
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
CIMS Hospital Pvt. Ltd
City
Sola
State/Province
Ahmedabad
ZIP/Postal Code
400022
Country
India
Facility Name
MIOT International Hospitals
City
Manapakkam
State/Province
Chennai-89
Country
India
Facility Name
All India Institute of Medical Science
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sanjivani Super Speciality Hospital Pvt Ltd
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Lokmanya Tilak General Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Max Smart Super Speciality Hospital
City
Saket
State/Province
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Max Super Speciality Hospital (A unit of Devki Devi Foundation)
City
Saket
State/Province
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Dayanand Medical College & Hospital
City
Ludhiāna
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Hospital del Prado
City
Acapulco
Country
Mexico
Facility Name
Icaro Investigaciones en Medicina
City
Chihuahua
Country
Mexico
Facility Name
HG de Cuernavaca Dr. Jose G Parres
City
Cuernavaca
Country
Mexico
Facility Name
JM Research
City
Cuernavaca
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurosciencias
City
Durango
Country
Mexico
Facility Name
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcade"
City
Guadalajara
Country
Mexico
Facility Name
Hospital San Javier
City
Guadalajara
Country
Mexico
Facility Name
Invesclinic MX
City
Guanajuato
Country
Mexico
Facility Name
CIMEZAP
City
Jalisco
Country
Mexico
Facility Name
Hospital Medica Sur
City
Mexico City
Country
Mexico
Facility Name
Hospital Clinica Nova
City
Monterrey
Country
Mexico
Facility Name
Hospital San Jose TEC Salud
City
Monterrey
Country
Mexico
Facility Name
ECI Estudios Clinicos Internacionales
City
Puebla
Country
Mexico
Facility Name
Hospital SMIQ
City
Queretaro
Country
Mexico
Facility Name
Investigacion Medica Sonora
City
Sonora
Country
Mexico
Facility Name
Sanatorio Santa Cruz de Toluca
City
Toluca
Country
Mexico
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cb2 0qq
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35699910
Citation
Gasparyan SB, Buenconsejo J, Kowalewski EK, Oscarsson J, Bengtsson OF, Esterline R, Koch GG, Berwanger O, Kosiborod MN. Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial. Ther Innov Regul Sci. 2022 Sep;56(5):785-794. doi: 10.1007/s43441-022-00420-1. Epub 2022 Jun 14.
Results Reference
derived
PubMed Identifier
34302745
Citation
Kosiborod MN, Esterline R, Furtado RHM, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Chopra V, Buenconsejo J, Langkilde AM, Ambery P, Tang F, Gosch K, Windsor SL, Akin EE, Soares RVP, Moia DDF, Aboudara M, Hoffmann Filho CR, Feitosa ADM, Fonseca A, Garla V, Gordon RA, Javaheri A, Jaeger CP, Leaes PE, Nassif M, Pursley M, Silveira FS, Barroso WKS, Lazcano Soto JR, Nigro Maia L, Berwanger O. Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):586-594. doi: 10.1016/S2213-8587(21)00180-7. Epub 2021 Jul 21.
Results Reference
derived

Learn more about this trial

Dapagliflozin in Respiratory Failure in Patients With COVID-19

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