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All Studies   Meta Analysis    Recent:   

Efficacy of Losartan in Hospitalized Patients With COVID-19–Induced Lung Injury

Puskarich et al., JAMA Network Open, doi:10.1001/jamanetworkopen.2022.2735, ALPS-IP, NCT04312009
Mar 2022  
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Mortality, day 90 -3% Improvement Relative Risk Mortality, day 28 -26% Ventilation -27% Oxygen therapy 3% Losartan  ALPS-IP  LATE TREATMENT  DB RCT Is late treatment with losartan beneficial for COVID-19? Double-blind RCT 205 patients in the USA (April 2020 - February 2021) Higher ventilation with losartan (not stat. sig., p=0.47) c19early.org Puskarich et al., JAMA Network Open, Mar 2022 Favorslosartan Favorscontrol 0 0.5 1 1.5 2+
RCT 205 hospitalized COVID-19 patients showing no significant difference in lung injury (PaO2:FiO2 ratio) at day 7 with losartan treatment, and no difference in clinical outcomes including mortality. Losartan was associated with more adverse events including acute kidney injury and need for vasopressors. Results suggest losartan is not beneficial and may cause harm in this setting.
risk of death, 3.0% higher, RR 1.03, p = 1.00, treatment 11 of 101 (10.9%), control 11 of 104 (10.6%), day 90.
risk of death, 25.9% higher, RR 1.26, p = 0.64, treatment 11 of 101 (10.9%), control 9 of 104 (8.7%), day 28.
risk of mechanical ventilation, 27.2% higher, RR 1.27, p = 0.47, treatment 21 of 100 (21.0%), control 17 of 103 (16.5%).
risk of oxygen therapy, 2.5% lower, RR 0.97, p = 0.66, treatment 89 of 101 (88.1%), control 94 of 104 (90.4%), NNT 44.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Puskarich et al., 16 Mar 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 36 authors, study period April 2020 - February 2021, trial NCT04312009 (history) (ALPS-IP).
This PaperLosartanAll
Efficacy of Losartan in Hospitalized Patients With COVID-19–Induced Lung Injury
MD Michael A Puskarich, MS Nicholas E Ingraham, MD Lisa H Merck, MD, MPH Brian E Driver, MD David A Wacker, Lauren Page Black, MD, MPH Alan E Jones, MD Courtney V Fletcher, PharmD Andrew M South, MS Thomas A Murray, PhD Christopher Lewandowski, MD Joseph Farhat, MD Justin L Benoit, MD, MS Michelle H Biros, MD, MS Kartik Cherabuddi, MD Jeffrey G Chipman, MD Timothy W Schacker, MD Faheem W Guirgis, Helen T Voelker, Joseph S Koopmeiners, Christopher J Tignanelli, Andrew C Nelson, Alex Hall, David Wright, Ronald A Reilkoff, Tyler Bold, Kenneth Beckman, Ryan Langlois, Matthew T Aliota, James Galbriath, Margaret Beyer, Chas Salmen, Dana Byrne, Brian Roberts, Nastasia James
JAMA Network Open, doi:10.1001/jamanetworkopen.2022.2735
IMPORTANCE SARS-CoV-2 viral entry may disrupt angiotensin II (AII) homeostasis, contributing to COVID-19 induced lung injury. AII type 1 receptor blockade mitigates lung injury in preclinical models, although data in humans with COVID-19 remain mixed. OBJECTIVE To test the efficacy of losartan to reduce lung injury in hospitalized patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS This blinded, placebo-controlled randomized clinical trial was conducted in 13 hospitals in the United States from April 2020 to February 2021. Hospitalized patients with COVID-19 and a respiratory sequential organ failure assessment score of at least 1 and not already using a renin-angiotensin-aldosterone system (RAAS) inhibitor were eligible for participation. Data were analyzed from April 19 to August 24, 2021. INTERVENTIONS Losartan 50 mg orally twice daily vs equivalent placebo for 10 days or until hospital discharge. MAIN OUTCOMES AND MEASURES The primary outcome was the imputed arterial partial pressure of oxygen to fraction of inspired oxygen (PaO 2 :FiO 2 ) ratio at 7 days. Secondary outcomes included ordinal COVID-19 severity; days without supplemental O 2 , ventilation, or vasopressors; and mortality. Losartan pharmacokinetics and RAAS components (AII, angiotensin-[1-7] and angiotensinconverting enzymes 1 and 2)] were measured in a subgroup of participants. RESULTS A total of 205 participants (mean [SD] age, 55.2 [15.7] years; 123 [60.0%] men) were randomized, with 101 participants assigned to losartan and 104 participants assigned to placebo. Compared with placebo, losartan did not significantly affect PaO 2 :FiO 2 ratio at 7 days (difference, -24.8 [95%, -55.6 to 6.1]; P = .12). Compared with placebo, losartan did not improve any secondary clinical outcomes and led to fewer vasopressor-free days than placebo (median [IQR], 9.4 [9.1-9.8] vasopressor-free days vs 8.7 [8.2-9.3] vasopressor-free days). CONCLUSIONS AND RELEVANCE This randomized clinical trial found that initiation of orally administered losartan to hospitalized patients with COVID-19 and acute lung injury did not improve PaO 2 :FiO 2 ratio at 7 days. These data may have implications for ongoing clinical trials.
Author Contributions: Dr Puskarich had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Puskarich, Ingraham, Wacker, South, Murray, Biros, Chipman, Schacker, Koopmeiners, Tignanelli. Acquisition, analysis, or interpretation of data: Puskarich, Ingraham, Merck, Driver, Wacker, Black, Jones, Fletcher, South, Murray, Lewandowski, Farhat, Benoit, Biros, Cherabuddi, Guirgis, Voelker, Koopmeiners, Tignanelli. Drafting of the manuscript: Puskarich, Ingraham, Fletcher, Murray, Schacker, Koopmeiners, Tignanelli. Funding/Support: The study was primarily funded by grant No. INV-017069 from the Bill and Melinda Gates Foundation. Dr South was supported by the NIH NHLBI (grants No. K23HL148394, L40HL148910, and R01HL146818). Pharmacokinetic data analyses were supported by grant No. R01AI124965 from the NIH (Dr Fletcher). Critical revision of the manuscript for important intellectual content Role of the Funder/Sponsor: The funder contributed to the study design, but had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Additional Contributions: Lee Winchester, BS, and Timothy Mykris, BS (Antiviral Pharmacology Laboratory, University of Nebraska Medical Center), assisted with quantitation of losartan and carboxylosartan..
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'10.1152/ajplung.00129.2021', 'article-title': 'A pilot study to assess the circulating renin-angiotensin system in ' 'COVID-19 acute respiratory failure.', 'volume': '321', 'author': 'Files', 'year': '2021', 'journal-title': 'Am J Physiol Lung Cell Mol Physiol'}, { 'issue': '5', 'key': 'zoi220109r7', 'doi-asserted-by': 'publisher', 'first-page': '702', 'DOI': '10.1016/j.pcad.2020.07.006', 'article-title': 'Letter to the Editor—circulating plasma levels of angiotensin II and ' 'aldosterone in patients with coronavirus disease 2019 (COVID-19): a ' 'preliminary report.', 'volume': '63', 'author': 'Henry', 'year': '2020', 'journal-title': 'Prog Cardiovasc Dis'}, { 'issue': '7047', 'key': 'zoi220109r8', 'doi-asserted-by': 'publisher', 'first-page': '112', 'DOI': '10.1038/nature03712', 'article-title': 'Angiotensin-converting enzyme 2 protects from severe acute lung ' 'failure.', 'volume': '436', 'author': 'Imai', 'year': '2005', 'journal-title': 'Nature'}, { 'issue': '5', 'key': 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Pharmacol'}, { 'issue': '6', 'key': 'zoi220109r12', 'doi-asserted-by': 'publisher', 'first-page': 'e52', 'DOI': '10.1097/EDE.0000000000001250', 'article-title': 'Re: association of inpatient use of angiotensin converting enzyme ' 'inhibitors and angiotensin II receptor blockers with mortality among ' 'patients with hypertension hospitalized with COVID-19.', 'volume': '31', 'author': 'Rouette', 'year': '2020', 'journal-title': 'Epidemiology'}, { 'issue': '6', 'key': 'zoi220109r13', 'doi-asserted-by': 'publisher', 'first-page': '571', 'DOI': '10.1007/s40256-020-00439-5', 'article-title': 'Mortality and disease severity among COVID-19 patients receiving ' 'renin-angiotensin system inhibitors: a systematic review and ' 'meta-analysis.', 'volume': '20', 'author': 'Hasan', 'year': '2020', 'journal-title': 'Am J Cardiovasc Drugs'}, { 'key': 'zoi220109r14', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.ijcha.2020.100627', 'article-title': 'Angiotensin-converting enzyme inhibitors and angiotensin-receptor ' 'blockers and the risk of COVID-19 infection or severe disease: ' 'systematic review and meta-analysis.', 'volume': '31', 'author': 'Caldeira', 'year': '2020', 'journal-title': 'Int J Cardiol Heart Vasc'}, { 'key': 'zoi220109r15', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.vph.2020.106805', 'article-title': 'RAAS inhibitors are not associated with mortality in COVID-19 patients: ' 'findings from an observational multicenter study in Italy and a ' 'meta-analysis of 19 studies.', 'volume': '135', 'author': 'COVID-19 RISk and Treatments (CORIST) Collaboration', 'year': '2020', 'journal-title': 'Vascul Pharmacol'}, { 'key': 'zoi220109r16', 'doi-asserted-by': 'publisher', 'DOI': '10.3389/fcvm.2020.585866', 'article-title': 'Comorbidities, cardiovascular therapies, and COVID-19 mortality: a ' 'nationwide, Italian Observational Study (ItaliCO).', 'volume': '7', 'author': 'Polverino', 'year': '2020', 'journal-title': 'Front Cardiovasc Med'}, { 'issue': '3', 'key': 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'Continuation versus discontinuation of renin-angiotensin system ' 'inhibitors in patients admitted to hospital with COVID-19: a ' 'prospective, randomised, open-label trial.', 'volume': '9', 'author': 'Cohen', 'year': '2021', 'journal-title': 'Lancet Respir Med'}, { 'key': 'zoi220109r1', 'unstructured': 'Worldometer. COVID-19 coronavirus pandemic. Accessed January 5, 2021. ' 'https://www.worldometers.info/coronavirus/'}, { 'key': 'zoi220109r18', 'unstructured': 'Centers for Disease Control and Prevention. Symptoms of COVID-19. ' 'Updated January 4, 2021. Accessed January 5, 2021. ' 'https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html'}, { 'key': 'zoi220109r29', 'doi-asserted-by': 'crossref', 'unstructured': 'Puskarich? M, Cummins? NW, Ingraham? N, . Effect of losartan on ' 'symptomatic outpatients with COVID-19: a randomized clinical trial.? ' 'SSRN. Preprint posted online February 17, 2021. doi:10.2139/ssrn.3787463', 'DOI': '10.2139/ssrn.3787463'}, { 'key': 'zoi220109r38', 'doi-asserted-by': 'crossref', 'unstructured': 'Duarte? M, Pelorosso? FG, Nicolosi? L, ? Telmisartan for treatment of ' 'Covid-19 patients: an open randomized clinical trial—preliminary ' 'report.? medRxiv. Preprint posted online August 13, 2020. ' 'doi:10.1101/2020.08.04.20167205', 'DOI': '10.1101/2020.08.04.20167205'}], 'container-title': 'JAMA Network Open', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2790162/puskarich_2022_oi_220109_1652198565.7699.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 5, 17]], 'date-time': '2022-05-17T16:45:19Z', 'timestamp': 1652805919000}, 'score': 1, 'resource': {'primary': {'URL': 'https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2790162'}}, 'subtitle': ['A Randomized Clinical Trial'], 'short-title': [], 'issued': {'date-parts': [[2022, 3, 16]]}, 'references-count': 40, 'journal-issue': {'issue': '3', 'published-print': {'date-parts': [[2022, 3, 1]]}}, 'URL': 'http://dx.doi.org/10.1001/jamanetworkopen.2022.2735', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.1101/2021.08.25.21262623', 'asserted-by': 'object'}]}, 'ISSN': ['2574-3805'], 'subject': [], 'container-title-short': 'JAMA Netw Open', 'published': {'date-parts': [[2022, 3, 16]]}}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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