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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\u2010glucose cotransporter\u20102 inhibitor, has shown significant cardio\u2010 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\u2010risk patients with COVID\u201019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>DARE\u201019 (NCT04350593) is an investigator\u2010initiated, collaborative, international, multicentre, randomized, double\u2010blind, placebo\u2010controlled study testing the dual hypotheses that dapagliflozin can reduce the incidence of cardiovascular, kidney and\/or respiratory complications or all\u2010cause mortality, or improve clinical recovery, in adult patients hospitalized with COVID\u201019 but not critically ill on admission. Eligible patients will have \u22651 cardiometabolic risk factor for COVID\u201019 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\u2010cause mortality, and the hierarchical composite endpoint of change in clinical status through day 30 of treatment. Safety of dapagliflozin in individuals with COVID\u201019 will be assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>DARE\u201019 will evaluate whether dapagliflozin can prevent COVID\u201019\u2010related complications and all\u2010cause mortality, or improve clinical recovery, and assess the safety profile of dapagliflozin in this patient population. Currently, DARE\u201019 is the first large randomized controlled trial investigating use of sodium\u2010glucose cotransporter 2 inhibitors in patients with COVID\u201019.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14296","type":"journal-article","created":{"date-parts":[[2020,12,15]],"date-time":"2020-12-15T14:38:48Z","timestamp":1608043128000},"page":"886-896","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["Effects of\n                    <b>da<\/b>\n                    pagliflozin on prevention of major clinical events and recovery in patients with\n                    <b>re<\/b>\n                    spiratory failure because of COVID\u2010\n                    <b>19<\/b>\n                    : Design and rationale for the DARE\u201019 study"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3750-9789","authenticated-orcid":false,"given":"Mikhail","family":"Kosiborod","sequence":"first","affiliation":[{"name":"Saint Luke's Mid America Heart Institute University of Missouri  Kansas City Missouri USA"},{"name":"The George Institute for Global Health University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Otavio","family":"Berwanger","sequence":"additional","affiliation":[{"name":"Academic Research Organization \u2010 Hospital Israelita Albert Einstein  S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary G.","family":"Koch","sequence":"additional","affiliation":[{"name":"The University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe","family":"Martinez","sequence":"additional","affiliation":[{"name":"National University of Cordoba  C\u00f3rdoba Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Mukhtar","sequence":"additional","affiliation":[{"name":"Experimental Medicine &amp; Immunotherapeutics Division, Department of Medicine University of Cambridge  Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subodh","family":"Verma","sequence":"additional","affiliation":[{"name":"Division of Cardiac Surgery, Keenan Research Centre for Biomedical Science Li Ka Shing Knowledge Institute of St. Michael's Hospital  Toronto Ontario Canada"},{"name":"Department of Surgery University of Toronto  Toronto Ontario Canada"},{"name":"Department of Pharmacology and Toxicology University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijay","family":"Chopra","sequence":"additional","affiliation":[{"name":"Max Super Speciality Hospital  New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Javaheri","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine  St Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Ambery","sequence":"additional","affiliation":[{"name":"Late\u2010Stage Development, CVRM, BioPharmaceuticals R&amp;D AstraZeneca  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4797-2208","authenticated-orcid":false,"given":"Samvel B.","family":"Gasparyan","sequence":"additional","affiliation":[{"name":"Late\u2010Stage Development, CVRM, BioPharmaceuticals R&amp;D AstraZeneca  Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Buenconsejo","sequence":"additional","affiliation":[{"name":"Late\u2010Stage Development, CVRM, BioPharmaceuticals R&amp;D AstraZeneca  Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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