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Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia

Geriak et al., Infectious Diseases and Therapy, doi:10.1007/s40121-021-00453-3, COVID-ARB, NCT04340557
May 2021  
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Mortality 6% Improvement Relative Risk ICU admission 53% Discharge 53% Hospitalization time 10% no CI Losartan  COVID-ARB  LATE TREATMENT  RCT Is late treatment with losartan beneficial for COVID-19? RCT 31 patients in the USA (March - July 2020) Lower ICU admission (p=0.6) and higher discharge (p=0.6), not sig. c19early.org Geriak et al., Infectious Diseases and.., May 2021 Favorslosartan Favorscontrol 0 0.5 1 1.5 2+
RCT 31 hospitalized COVID-19 patients with mild hypoxemia showing no significant difference in mechanical ventilation, ICU admission, or mortality with addition of losartan to standard care.
risk of death, 6.2% lower, RR 0.94, p = 1.00, treatment 1 of 16 (6.2%), control 1 of 15 (6.7%), NNT 240.
risk of ICU admission, 53.1% lower, RR 0.47, p = 0.60, treatment 1 of 16 (6.2%), control 2 of 15 (13.3%), NNT 14.
risk of no hospital discharge, 53.1% lower, RR 0.47, p = 0.60, treatment 1 of 16 (6.2%), control 2 of 15 (13.3%), NNT 14.
hospitalization time, 10.0% lower, relative time 0.90, treatment 16, control 15.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Geriak et al., 11 May 2021, Randomized Controlled Trial, USA, peer-reviewed, median age 53.0, 8 authors, study period 30 March, 2020 - 4 July, 2020, trial NCT04340557 (history) (COVID-ARB). Contact: matthew.geriak@sharp.com.
This PaperLosartanAll
Randomized Prospective Open Label Study Shows No Impact on Clinical Outcome of Adding Losartan to Hospitalized COVID-19 Patients with Mild Hypoxemia
Matthew Geriak, Fadi Haddad, Ravina Kullar, Kristina L Greenwood, Mackenzie Habib, Cole Habib, David Willms, George Sakoulas
Infectious Diseases and Therapy, doi:10.1007/s40121-021-00453-3
Introduction: Despite considerable scientific debate, there have been no prospective clinical studies on the effects of angiotensin II receptor blockers (ARBs) on the course of COVID-19 infection. Losartan is the ARB that was chosen to be tested in this study. Methods: Patients with COVID-19 and mild hypoxia (receipt of B 3 L/min O 2 by nasal cannula) admitted to three hospitals were randomized in a 1:1 ratio within 72 h of SARS-CoV-2 nucleic acid testing confirmation to prospectively receive standard of care (SOC) alone or SOC plus losartan 12.5 mg orally every 12 h for 10 days or until hospital discharge, with the option to titrate upward dependent on blood pressure tolerability. Primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Subjects were followed until discharge to home or until an endpoint was met in the hospital. Results: Sixteen subjects received an ARB plus SOC and 15 subjects received SOC alone. The median age was 53 years for both groups. Median time from hospital admission to study enrollment was 2 days (range 1-6) for the ARB group and 2 days (range 1-4) for the SOC group. Mean Charlson comorbidity index was 2 for both groups. One subject in each group achieved the composite endpoint. Conclusion: This small prospective randomized open-label study showed no clinically significant impacts of ARB therapy in mildly hypoxemic patients hospitalized with COVID-19 early in the pandemic. A larger prospective randomized placebo-controlled trial would be needed to confirm these findings or capture less pronounced effects and probably should focus on outpatients earlier in disease course.
Authorship. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published. All authors were active participants in at least one category of study design, study execution, data gathering and organization, data analysis and statistics, or manuscript preparation. Authors
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' 'https://doi.org/10.1016/S0140-6736(20)31022-9.', 'journal-title': 'Lancet'}, { 'key': '453_CR27', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2015301', 'author': 'JD Goldman', 'year': '2020', 'unstructured': 'Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in ' 'patients with severe Covid-19 [published online ahead of print, 2020 May ' '27]. N Engl J Med. 2020. https://doi.org/10.1056/NEJMoa2015301.', 'journal-title': 'N Engl J Med.'}, { 'key': '453_CR28', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2021436', 'author': 'P Horby', 'year': '2020', 'unstructured': 'RECOVERY Collaborative Group, Horby P, Lim WS, et al. Dexamethasone in ' 'hospitalized patients with Covid-19—preliminary report [published online ' 'ahead of print, 2020 Jul 17]. N Engl J Med. 2020. ' 'https://doi.org/10.1056/NEJMoa2021436.', 'journal-title': 'N Engl J Med.'}, { 'issue': '371', 'key': '453_CR29', 'doi-asserted-by': 'publisher', 'first-page': 'm4362', 'DOI': '10.1136/bmj.m4362', 'volume': '11', 'author': 'E Mahase', 'year': '2020', 'unstructured': 'Mahase E. Covid-19: FDA authorises neutralising antibody bamlanivimab ' 'for non-admitted patients. BMJ. 2020;11(371):m4362. ' 'https://doi.org/10.1136/bmj.m4362.', 'journal-title': 'BMJ'}, { 'key': '453_CR30', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2023184', 'author': 'H Pan', 'year': '2020', 'unstructured': 'WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, ' 'Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández ' 'García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, ' 'Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, ' 'Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani ' 'S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, ' 'García PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, ' 'Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, ' 'Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel ' 'O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes ' 'EP, Perola M, Portolés A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers ' 'CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, ' 'Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Røttingen JA, Swaminathan ' 'S. Repurposed antiviral drugs for Covid-19—interim WHO solidarity trial ' 'results. N Engl J Med. 2020. https://doi.org/10.1056/NEJMoa2023184 (Epub ' 'ahead of print).', 'journal-title': 'N Engl J Med.'}], 'container-title': 'Infectious Diseases and Therapy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40121-021-00453-3.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s40121-021-00453-3/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s40121-021-00453-3.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 8, 10]], 'date-time': '2021-08-10T17:20:07Z', 'timestamp': 1628616007000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s40121-021-00453-3'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 5, 11]]}, 'references-count': 30, 'journal-issue': {'issue': '3', 'published-print': {'date-parts': [[2021, 9]]}}, 'alternative-id': ['453'], 'URL': 'http://dx.doi.org/10.1007/s40121-021-00453-3', 'relation': {}, 'ISSN': ['2193-8229', '2193-6382'], 'subject': [], 'container-title-short': 'Infect Dis Ther', 'published': {'date-parts': [[2021, 5, 11]]}, 'assertion': [ { 'value': '28 April 2021', 'order': 1, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '11 May 2021', 'order': 2, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}]}
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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