COVID-19Phase 3DARE-19NCT04350593
Dapagliflozin in Respiratory Failure in Patients With COVID-19
A Phase 3 study testing Dapagliflozin 10 milligram (mg) in people with COVID-19, run by Saint Luke's Health System at 95 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Dapagliflozin 10 milligram (mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,250 participants
- Where
- 95 sitesin 7 countries
- Study dates
- 22 Apr 2020to 11 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
95 sites in 7 countries.
95 sites in 7 countries
Brazil35 sites
Centro de Pesquisa Clínica do Coração
Aracaju, Sergipe, 49055-530
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, 63180-000
Fundação Pio XII
Barretos, 14784-400
Associação Dr. Bartholomeu Tacchini
Bento Gonçalves, Rio Grande do Sul, 95700-084
Faculdade de Medicina de Botucatu, UNESP
Botucatu, São Paulo, 18618-687
Hospital Coração do Brasil
Brasília, Federal District, 70390-700
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-904
Hospital São José - Criciúma
Criciúma, Santa Catarina, 88811-250
Hospital EMEC e Hospital da Cidade
Feira de Santana, Estado de Bahia, 44035-010
Unimed de Fortaleza
Fortaleza, Ceará, 60055-172
Hospital de Messejana Dr Carlos Alberto Studart Gomes
Fortaleza, Ceará, 60840-285
Liga de Hipertensão Arterial
Goiânia, Goiás, 74690-900
Hospital e Clínica São Roque
Ipiaú, Estado de Bahia, 45570-000
IPEMI- Instituto de Pesquisas Médicas de Itajaí
Itajaí, Santa Catarina, 88301-303
Hospital Municipal São José
Joinville, Santa Catarina, 74605-050
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, 89228-025
Centro de Pesquisa Dr. Marco Mota
Maceió, Alagoas, 57051-160
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte, 59037-170
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, 37904-020
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, 90110-270
Hospital Regional Deputado Luis Eduardo Magalhães
Porto Seguro, Estado de Bahia, 45810-000
PROCAPE
Recife, Pernambuco, 50100-060
Unimed Ribeirao Preto
Ribeirão Preto, São Paulo, 14110-000
Hospital Naval Marcílio Dias
Rio de Janeiro, 20725-090
Hospital Cárdio Pulmonar
Salvador, Estado de Bahia, 41950-275
Fundação do ABC (Hospital Estadual Mário Covas)
Santo André, São Paulo, 09090-790
Centro Integrado de Pesquisas
São José do Rio Preto, São Paulo, 15090-000
Hospital Moriah
São Paulo, 04083-002
Hospital Santa Paula
São Paulo, 04556-100
InCor - Instituto do Coração do Hospital das Clínicas FMUSP
São Paulo, 05403-900
Hospital Estadual Jayme dos Santos Neves
Serra, Espírito Santo, 29166-828
Hospital São Domingos - Unimed Uberaba
Uberaba, Minas Gerais, 38025-440
Santa Casa de Votuporanga
Votuporanga, São Paulo, 15500-003
United States22 sites
McLaren Health Care
Auburn Hills, Michigan, 48326
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Maimonides Medical Center
Brooklyn, New York, 11219
Lahey Health
Burlington, Massachusetts, 01805
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
NorthShore University HealthSystem
Evanston, Illinois, 60201
Heart Group of the Eastern Shore
Fairhope, Alabama, 36532
Baylor College of Medicine
Houston, Texas, 77030
Ascension - St. Vincent
Indianapolis, Indiana, 46260
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Loyola University
Maywood, Illinois, 60153
Clinical Trials Network of Tennessee
Memphis, Tennessee, 38103
Baptist Hospital of Miami
Miami, Florida, 33176
Sentara Healthcare
Norfolk, Virginia, 23507
Rhode Island Hospital
Providence, Rhode Island, 02903
St. Francis Hospital
Roslyn, New York, 11576
Washington University School of Medicine
St Louis, Missouri, 63110
Jacobi Medical Center
The Bronx, New York, 10461
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Mexico16 sites
Hospital del Prado
Acapulco
Icaro Investigaciones en Medicina
Chihuahua City
HG de Cuernavaca Dr. Jose G Parres
Cuernavaca
JM Research
Cuernavaca
Instituto de Investigaciones Aplicadas a la Neurosciencias
Durango
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcade"
Guadalajara
Hospital San Javier
Guadalajara
Invesclinic MX
Guanajuato City
CIMEZAP
Jalisco
Hospital Medica Sur
Mexico City
Hospital Clinica Nova
Monterrey
Hospital San Jose TEC Salud
Monterrey
ECI Estudios Clinicos Internacionales
Puebla City
Hospital SMIQ
Querétaro
Investigacion Medica Sonora
Sonora
Sanatorio Santa Cruz de Toluca
Toluca
Argentina11 sites
Fundación Favaloro
Buenos Aires
Hospital Español
Buenos Aires
Hospital Fernández
Buenos Aires
Hospital Pirovano
Buenos Aires
Hospital Santojanni
Buenos Aires
Sanatorio Anchorena
Buenos Aires
Sanatorio Güemes
Buenos Aires
Clínica Vélez Sarsfield
Córdoba
Hospital San Roque
Córdoba
Sanatorio Privado Duarte Quiros de Clinica Colombo S.A.
Córdoba
Clínica de Especialidades Villa María
Villa María, Province of Córdoba
India8 sites
Sanjivani Super Speciality Hospital Pvt Ltd
Ahmedabad, Gujarat, 380015
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
MIOT International Hospitals
Manapakkam, Chennai-89
Lokmanya Tilak General Hospital
Mumbai, Maharashtra, 400022
All India Institute of Medical Science
New Delhi, National Capital Territory of Delhi, 110029
Max Smart Super Speciality Hospital
Sāket, New Delhi, 110017
Max Super Speciality Hospital (A unit of Devki Devi Foundation)
Sāket, New Delhi, 110017
CIMS Hospital Pvt. Ltd
Sola, Ahmedabad, 400022
Canada2 sites
Halton Healthcare Services
Oakville, Ontario
Lakeridge Health
Oshawa, Ontario
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Dapagliflozin 10 milligram (mg), Placebo
- Keywords
- sodium-glucose cotransporter-2 inhibitor (SGLT2i), dapagliflozin, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 milligram (mg)Drug
Also called Farxiga
Active Comparator: Dapagliflozin 10 mg
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg | Active comparator | Dapagliflozin 10 mg daily Receives: Drug: Dapagliflozin 10 milligram (mg) |
| Placebo | Placebo comparator | Dapagliflozin matching placebo 10 mg daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Randomization through Day 30
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
Measured: Randomization through Day 30
Secondary outcomes (5)
Time to Hospital Discharge
Time to hospital discharge (refers to index hospitalization only).
Median time to hospital discharge is presented in days.
Measured: Randomization through Day 30
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.
Measured: Randomization through Day 30
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.
Measured: Randomization through Day 30
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.
Measured: Randomization through Day 30
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.
Measured: Randomization through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start22 Apr 2020
- Primary completion31 Mar 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri, AstraZeneca, Emerald Clinical Inc.
- Responsible party
- Sponsor
- Investigators
- Mikhail Kosiborod, MD, Study chair, Saint Luke's Mid America Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350593
- Sponsor's protocol ID
- D1690C00081
- Other IDs
- ESR-20-20653
- Acronym
- DARE-19
- Status last verified
- May 2022
- First submitted
- 14 Apr 2020
- Last updated
- 10 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel Jawad M, Furtado RHM, Esterline R, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Langkilde AM, Ambery P, Patel S, Gosch K, Windsor SL, Soares RVP, Moia DDF, Aboudara M, Javaheri A, Saraiva JFK, Maia LN, Berwanger O, Sauer AJ, Kosiborod MN. Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial. Cardiovasc Diabetol. 2025 Jul 30;24(1):307. doi: 10.1186/s12933-025-02875-6.
PubMed 40739638Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818Gasparyan 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.
PubMed 35699910Kosiborod 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.
PubMed 34302745
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04350593
- Acronym / sponsor ID
- DARE-19 / D1690C00081
- Conditions
- COVID-19
- Keywords
- sodium-glucose cotransporter-2 inhibitor (SGLT2i), dapagliflozin, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- St. Luke's Hospital, Kansas City, Missouri, AstraZeneca, Emerald Clinical Inc.
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Posted 13 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg | Active comparator | Drug: Dapagliflozin 10 milligram (mg)Dapagliflozin 10 mg daily |
| Placebo | Placebo comparator | Drug: PlaceboDapagliflozin matching placebo 10 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 milligram (mg)Also: FarxigaActive Comparator: Dapagliflozin 10 mg | Drug | Dapagliflozin 10mg |
| PlaceboPlacebo Comparator | Drug | Placebo |
Primary outcome
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 frame: 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
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.
Time frame: 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
5 secondary outcomes
Time to Hospital Discharge
Time frame: Randomization through Day 30
Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
Time frame: Randomization through Day 30
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)
Time frame: Randomization through Day 30
Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause
Time frame: Randomization through Day 30
Time to Death From Any Cause
Time frame: Randomization through Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40739638Abdel Jawad M, Furtado RHM, Esterline R, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Langkilde AM, Ambery P, Patel S, Gosch K, Windsor SL, Soares RVP, Moia DDF, Aboudara M, Javaheri A, Saraiva JFK, Maia LN, Berwanger O, Sauer AJ, Kosiborod MN. Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial. Cardiovasc Diabetol. 2025 Jul 30;24(1):307. doi: 10.1186/s12933-025-02875-6.
- Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Derived from this study: PubMed 35699910Gasparyan 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.
- Derived from this study: PubMed 34302745Kosiborod 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Kosiborod, MD study chair
Saint Luke's Mid America Heart Institute
95 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin 10 milligram (mg) in people with COVID-19, run by Saint Luke's Health System at 95 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Brazil, United States, Mexico, Argentina, India and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: Randomization through Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350593, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.