Evidence map›Paper›PMID 33319454›Full record

ArticleDiabetes, obesity & metabolism2021

Effects of dapagliflozin on prevention of major clinical events and recovery in patients with respiratory failure because of COVID-19: Design and rationale for the DARE-19 study.

Mikhail Kosiborod, Otavio Berwanger, Gary G Koch, Felipe Martinez, Omar Mukhtar, Subodh Verma, Vijay Chopra, Ali Javaheri, Philip Ambery, Samvel B Gasparyan and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial Protocol
In one paragraph

Article in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04350593 (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), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04350593 phase3completednot on this map

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

TypeinterventionalSponsorSaint Luke's Health SystemRan2020 to 2021Enrolled1,250ConditionsCOVID-19ArmsDapagliflozin 10 milligram (mg), Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  11. The Diabetic Cardiorenal Nexus.International journal of molecular sciences · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 9 countries.

Mikhail KosiborodSaint Luke's Mid America Heart Institute, University of Missouri, Kansas City, Missouri, USA.ORCID 0000-0002-3750-9789
Otavio BerwangerAcademic Research Organization - Hospital Israelita Albert Einstein, São Paulo, Brazil.
Gary G KochThe University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Felipe MartinezNational University of Cordoba, Córdoba, Argentina.
Omar MukhtarExperimental Medicine & Immunotherapeutics Division, Department of Medicine, University of Cambridge, Cambridge, UK.
Subodh VermaDivision of Cardiac Surgery, Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
Vijay ChopraMax Super Speciality Hospital, New Delhi, India.
Ali JavaheriWashington University School of Medicine, St Louis, Missouri, USA.
Philip AmberyLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Samvel B GasparyanLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0002-4797-2208
Joan BuenconsejoLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
C David SjöströmLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anna Maria LangkildeLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Jan OscarssonLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Russell EsterlineLate-Stage Development, CVRM, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
AstraZeneca (Sweden) · SEAstraZeneca (Spain) · ESHospital Israelita Albert Einstein · BRMax Super Speciality Hospital · INSaint Luke's Health System · USSt. Michael's Hospital · CAUniversidad Nacional de Córdoba · ARUniversity of Cambridge · GBUniversity of North Carolina at Chapel Hill · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCoronavirus disease 2019 (COVID-19) is caused by a novel severe acute respiratory syndrome coronavirus 2. It can lead to multiorgan failure, including respiratory and cardiovascular decompensation, and kidney injury, with significant associated morbidity and mortality, particularly in patients with underlying metabolic, cardiovascular, respiratory or kidney disease. Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, has shown significant cardio- and renoprotective benefits in patients with type 2 diabetes (with and without atherosclerotic cardiovascular disease), heart failure and chronic kidney disease, and may provide similar organ protection in high-risk patients with COVID-19. MATERIALS AND

methodsDARE-19 (NCT04350593) is an investigator-initiated, collaborative, international, multicentre, randomized, double-blind, placebo-controlled study testing the dual hypotheses that dapagliflozin can reduce the incidence of cardiovascular, kidney and/or respiratory complications or all-cause mortality, or improve clinical recovery, in adult patients hospitalized with COVID-19 but not critically ill on admission. Eligible patients will have ≥1 cardiometabolic risk factor for COVID-19 complications. Patients will be randomized 1:1 to dapagliflozin 10 mg or placebo. Primary efficacy endpoints are time to development of new or worsened organ dysfunction during index hospitalization, or all-cause mortality, and the hierarchical composite endpoint of change in clinical status through day 30 of treatment. Safety of dapagliflozin in individuals with COVID-19 will be assessed.

conclusionsDARE-19 will evaluate whether dapagliflozin can prevent COVID-19-related complications and all-cause mortality, or improve clinical recovery, and assess the safety profile of dapagliflozin in this patient population. Currently, DARE-19 is the first large randomized controlled trial investigating use of sodium-glucose cotransporter 2 inhibitors in patients with COVID-19.

Indexed as

COVID-19 Drug TreatmentMortalityAtherosclerosisBenzhydryl CompoundsCardiometabolic Risk FactorsCardiovascular DiseasesCause of DeathComorbidityCOVID-19Diabetes Mellitus, Type 2Disease ProgressionDouble-Blind MethodGlucosidesHeart FailureHumansHypertensionBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitorsclinical trialdapagliflozinphase III studyrandomized trialSGLT2 inhibitor

Identifiers

PMID33319454
PMCPMC8049025
OpenAlexW3110989969

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.