{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T23:59:37Z","timestamp":1793059177304,"version":"4.5.0"},"reference-count":38,"publisher":"American Medical Association (AMA)","issue":"14","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,4,11]]},"abstract":"Importance<\/jats:title>Preclinical models suggest dysregulation of the renin-angiotensin system (RAS) caused by SARS-CoV-2 infection may increase the relative activity of angiotensin II compared with angiotensin (1-7) and may be an important contributor to COVID-19 pathophysiology.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate the efficacy and safety of RAS modulation using 2 investigational RAS agents, TXA-127 (synthetic angiotensin [1-7]) and TRV-027 (an angiotensin II type 1 receptor\u2013biased ligand), that are hypothesized to potentiate the action of angiotensin (1-7) and mitigate the action of the angiotensin II.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>Two randomized clinical trials including adults hospitalized with acute COVID-19 and new-onset hypoxemia were conducted at 35 sites in the US between July 22, 2021, and April 20, 2022; last follow-up visit: July 26, 2022.<\/jats:p><\/jats:sec>Interventions<\/jats:title>A 0.5-mg\/kg intravenous infusion of TXA-127 once daily for 5 days or placebo. A 12-mg\/h continuous intravenous infusion of TRV-027 for 5 days or placebo.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was oxygen-free days, an ordinal outcome that classifies a patient\u2019s status at day 28 based on mortality and duration of supplemental oxygen use; an adjusted odds ratio (OR) greater than 1.0 indicated superiority of the RAS agent vs placebo. A key secondary outcome was 28-day all-cause mortality. Safety outcomes included allergic reaction, new kidney replacement therapy, and hypotension.<\/jats:p><\/jats:sec>Results<\/jats:title>Both trials met prespecified early stopping criteria for a low probability of efficacy. Of 343 patients in the TXA-127 trial (226 [65.9%] aged 31-64 years, 200 [58.3%] men, 225 [65.6%] White, and 274 [79.9%] not Hispanic), 170 received TXA-127 and 173 received placebo. Of 290 patients in the TRV-027 trial (199 [68.6%] aged 31-64 years, 168 [57.9%] men, 195 [67.2%] White, and 225 [77.6%] not Hispanic), 145 received TRV-027 and 145 received placebo. Compared with placebo, both TXA-127 (unadjusted mean difference, \u22122.3 [95% CrI, \u22124.8 to 0.2]; adjusted OR, 0.88 [95% CrI, 0.59 to 1.30]) and TRV-027 (unadjusted mean difference, \u22122.4 [95% CrI, \u22125.1 to 0.3]; adjusted OR, 0.74 [95% CrI, 0.48 to 1.13]) resulted in no difference in oxygen-free days. In the TXA-127 trial, 28-day all-cause mortality occurred in 22 of 163 patients (13.5%) in the TXA-127 group vs 22 of 166 patients (13.3%) in the placebo group (adjusted OR, 0.83 [95% CrI, 0.41 to 1.66]). In the TRV-027 trial, 28-day all-cause mortality occurred in 29 of 141 patients (20.6%) in the TRV-027 group vs 18 of 140 patients (12.9%) in the placebo group (adjusted OR, 1.52 [95% CrI, 0.75 to 3.08]). The frequency of the safety outcomes was similar with either TXA-127 or TRV-027 vs placebo.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In adults with severe COVID-19, RAS modulation (TXA-127 or TRV-027) did not improve oxygen-free days vs placebo. These results do not support the hypotheses that pharmacological interventions that selectively block the angiotensin II type 1 receptor or increase angiotensin (1-7) improve outcomes for patients with severe COVID-19.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04924660<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2023.3546","type":"journal-article","created":{"date-parts":[[2023,4,11]],"date-time":"2023-04-11T15:04:43Z","timestamp":1681225483000},"page":"1170","source":"Crossref","is-referenced-by-count":52,"title":["Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor\u2013Biased Ligand in Adults With COVID-19"],"prefix":"10.1001","volume":"329","author":[{"given":"Wesley H.","family":"Self","sequence":"first","affiliation":[{"name":"Vanderbilt Institute for Clinical and Translational Research, Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew S.","family":"Shotwell","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin W.","family":"Gibbs","sequence":"additional","affiliation":[{"name":"Department of Medicine, Wake Forest University, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjolein","family":"de Wit","sequence":"additional","affiliation":[{"name":"Department of Medicine, Virginia Commonwealth University, Richmond"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. 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