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All Studies   Meta Analysis    Recent:   

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

Goldman et al., NEJM, doi:10.1056/NEJMoa2015301
May 2020  
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Mortality 22% Improvement Relative Risk HCQ for COVID-19  Goldman et al.  LATE TREATMENT Is late treatment with HCQ beneficial for COVID-19? Retrospective 397 patients in multiple countries Lower mortality with HCQ (not stat. sig., p=0.46) c19hcq.org Goldman et al., NEJM, May 2020 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19hcq.org
Study focused on remdesivir but with results for HCQ in the supplementary appendix, showing 9% death with HCQ versus 12% control, unadjusted relative risk uRR 0.78, p = 0.46.
Although the 22% lower mortality is not statistically significant, it is consistent with the significant 26% lower mortality [22‑30%] from meta analysis of the 249 mortality results to date.
This study is excluded in the after exclusion results of meta analysis: unadjusted results with no group details.
Study covers remdesivir and HCQ.
risk of death, 22.3% lower, RR 0.78, p = 0.46, treatment 10 of 109 (9.2%), control 34 of 288 (11.8%), NNT 38.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Goldman et al., 27 May 2020, retrospective, multiple countries, peer-reviewed, 26 authors.
This PaperHCQAll
Remdesivir for 5 or 10 Days in Patients with Severe Covid-19
M.D Jason D Goldman, M.P.H David C B Lye, B.S David S Hui, M.D Kristen M Marks, M.D Raffaele Bruno, M.D Rocio Montejano, M.D Christoph D Spinner, M.D Massimo Galli, M.D Mi-Young Ahn, M.D Ronald G Nahass, M.D Yao-Shen Chen, M.D Devi Sengupta, M.D Robert H Hyland, M.D Anu O Osinusi, M.D Huyen Cao, M.S Christiana Blair, Ph.D Xuelian Wei, M.D Anuj Gaggar, Ph.D Diana M Brainard, M.D William J Towner, M.D Jose Muñoz, M.D Kathleen M Mullane, Pharm.D Francisco M Marty, M.D Karen T Tashima, M.D George Diaz, M.D Aruna Subramanian
New England Journal of Medicine, doi:10.1056/nejmoa2015301
BACKGROUND Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). METHODS We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. RESULTS In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). CONCLUSIONS In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.
Acute respiratory distress syndrome 1 (<1) 5 Respiratory distress 3
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' '— both in Washington; the National Center for Infectious ' 'Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng ' 'Hospital, Singapore (D.C.B.L.); the Chinese University of Hong ' 'Kong–Prince of Wales Hospital, Hong Kong (D.S.H.); New ' 'York–Presbyterian Hospital and Weill Cornell Medicine, New York ' '(K.M. Marks); Malattie...'}]}, { 'given': 'Karen T.', 'family': 'Tashima', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Swedish Center for Research and Innovation, Swedish ' 'Medical Center, and the University of Washington, Seattle ' '(J.D.G.), and Providence Regional Medical Center, Everett (G.D.) ' '— both in Washington; the National Center for Infectious ' 'Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng ' 'Hospital, Singapore (D.C.B.L.); the Chinese University of Hong ' 'Kong–Prince of Wales Hospital, Hong Kong (D.S.H.); New ' 'York–Presbyterian Hospital and Weill Cornell Medicine, New York ' '(K.M. Marks); Malattie...'}]}, { 'given': 'George', 'family': 'Diaz', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Swedish Center for Research and Innovation, Swedish ' 'Medical Center, and the University of Washington, Seattle ' '(J.D.G.), and Providence Regional Medical Center, Everett (G.D.) ' '— both in Washington; the National Center for Infectious ' 'Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng ' 'Hospital, Singapore (D.C.B.L.); the Chinese University of Hong ' 'Kong–Prince of Wales Hospital, Hong Kong (D.S.H.); New ' 'York–Presbyterian Hospital and Weill Cornell Medicine, New York ' '(K.M. Marks); Malattie...'}]}, { 'given': 'Aruna', 'family': 'Subramanian', 'sequence': 'additional', 'affiliation': [ { 'name': 'From the Swedish Center for Research and Innovation, Swedish ' 'Medical Center, and the University of Washington, Seattle ' '(J.D.G.), and Providence Regional Medical Center, Everett (G.D.) ' '— both in Washington; the National Center for Infectious ' 'Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng ' 'Hospital, Singapore (D.C.B.L.); the Chinese University of Hong ' 'Kong–Prince of Wales Hospital, Hong Kong (D.S.H.); New ' 'York–Presbyterian Hospital and Weill Cornell Medicine, New York ' '(K.M. Marks); Malattie...'}]}], 'member': '150', 'reference': [ {'key': 'r1', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMe2002387'}, {'key': 'r4', 'doi-asserted-by': 'publisher', 'DOI': '10.1002/bjs.11627'}, {'key': 'r7', 'doi-asserted-by': 'publisher', 'DOI': '10.1001/jama.2020.6775'}, {'key': 'r8', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMe2005477'}, {'key': 'r9', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2001282'}, {'key': 'r10', 'doi-asserted-by': 'publisher', 'DOI': '10.1073/pnas.1922083117'}, {'key': 'r11', 'doi-asserted-by': 'publisher', 'DOI': '10.1126/scitranslmed.aal3653'}, {'key': 'r12', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/s41467-019-13940-6'}, {'key': 'r13', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/nature17180'}, {'key': 'r16', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/s41422-020-0282-0'}, {'key': 'r17', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa1910993'}, {'key': 'r20', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2002032'}, {'key': 'r21', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S0140-6736(20)31022-9'}, {'key': 'r22', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S0140-6736(20)31023-0'}, { 'key': 'r23', 'doi-asserted-by': 'crossref', 'first-page': '1813', 'DOI': '10.1056/NEJMoa2007764', 'volume': '382', 'author': 'Beigel JH', 'year': '2020', 'journal-title': 'N Engl J Med'}, {'key': 'r24', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/S2468-1253(20)30057-1'}], 'container-title': 'New England Journal of Medicine', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'http://www.nejm.org/doi/pdf/10.1056/NEJMoa2015301', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2020, 11, 4]], 'date-time': '2020-11-04T21:57:59Z', 'timestamp': 1604527079000}, 'score': 1, 'resource': {'primary': {'URL': 'http://www.nejm.org/doi/10.1056/NEJMoa2015301'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2020, 11, 5]]}, 'references-count': 16, 'journal-issue': {'issue': '19', 'published-print': {'date-parts': [[2020, 11, 5]]}}, 'alternative-id': ['10.1056/NEJMoa2015301'], 'URL': 'http://dx.doi.org/10.1056/NEJMoa2015301', 'relation': {}, 'ISSN': ['0028-4793', '1533-4406'], 'subject': ['General Medicine'], 'container-title-short': 'N Engl J Med', 'published': {'date-parts': [[2020, 11, 5]]}}
Late treatment
is less effective
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