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Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results

SOLIDARITY Trial Consortium, NEJM, doi:10.1056/NEJMoa2023184 (date from preprint), SOLIDARITY, NCT04315948
Oct 2020  
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Mortality -19% Improvement Relative Risk HCQ  SOLIDARITY  LATE TREATMENT  RCT Is late treatment with HCQ beneficial for COVID-19? RCT 1,853 patients in multiple countries (March - October 2020) Higher mortality with HCQ (not stat. sig., p=0.23) SOLIDARITY Trial Consortium, NEJM, Oct 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.
WHO SOLIDARITY open-label trial with 954 very late stage (64% on oxygen/ventilation) HCQ patients, mortality relative risk RR 1.19 [0.89-1.59], p=0.23.
HCQ dosage very high as in RECOVERY, 1.6g in the first 24 hours, 9.6g total over 10 days, only 25% less than the high dosage that Borba et al. show greatly increases risk (OR 2.8)1.
Authors state they do not know the weight or obesity status of patients to analyze toxicity (since they do not adjust dosage based on patient weight, toxicity may be higher in patients of lower weight).
KM curves show a spike in HCQ mortality days 5-7, corresponding to ~90% of the total excess seen at day 28 (a similar spike is seen in the RECOVERY trial).
Almost all excess mortality is from ventilated patients.
Authors refer to a lack of excess mortality in the first few days to suggest a lack of toxicity, but they are ignoring the very long half-life of HCQ and the dosing regimen - much higher levels of HCQ will be reached later. Increased mortality in Borba et al. occurred after 2 days.
An unspecified percentage used the more toxic CQ. No placebo used.
For more on the dosing problems see2, also noting that concentrations vary substantially in different tissues and lung concentration may be >30x plasma concentration.
This study is excluded in the after exclusion results of meta analysis: excessive dosage in late stage patients, results do not apply to typical dosages; very late stage, >50% on oxygen/ventilation at baseline.
Study covers remdesivir and HCQ.
risk of death, 19.0% higher, RR 1.19, p = 0.23, treatment 104 of 947 (11.0%), control 84 of 906 (9.3%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
SOLIDARITY Trial Consortium et al., 15 Oct 2020, Randomized Controlled Trial, multiple countries, peer-reviewed, baseline oxygen required 64.0%, 15 authors, study period 22 March, 2020 - 4 October, 2020, trial NCT04315948 (history) (SOLIDARITY).
This PaperHCQAll
Abstract: medRxiv preprint doi: version posted October 15, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 1 MedRxiv (October 15) version Repurposed antiviral drugs for COVID-19 –interim WHO SOLIDARITY trial results WHO Solidarity trial consortium* *A complete list of SOLIDARITY Trial investigators is provided in the Supplementary Appendix. Hongchao Pan, Ph.D., Richard Peto, F.R.S., Quarraisha Abdool Karim, Ph.D., Marissa Alejandria M.D., M.Sc., Ana Maria HenaoRestrepo, M.D., M.Sc., César Hernández García M.D., Ph.D., Marie-Paule Kieny Ph.D., Reza Malekzadeh M.D., Srinivas Murthy M.D. C.M., Marie-Pierre Preziosi M.D., Ph.D., Srinath Reddy M.D., D.M., Mirta Roses Periago M. D., Vasee Sathiyamoorthy B.M.B.Ch., Ph.D., John-Arne Røttingen M.D., Ph.D., and Soumya Swaminathan M.D. , as the members of the Writing Committee, assume responsibility for the content and integrity of this article. International Steering Committee *National PI; †National Coordinator; ‡Executive Group;§Discovery add-on study. Albania: University Hospital Centre, Tirana N Como*; National Agency for Medicines and Medical Devices N Sinani†. Argentina: Fundación del Centro de Estudios Infectológicos G Lopardo*; National Academy of Sciences of Buenos Aires M Roses Periago†‡. Austria:§. Belgium:§. Brazil: Oswaldo Cruz Foundation EP Nunes*, PPS Reges†. Canada: University of British Columbia S Murthy*‡; Public Health Agency of Canada M Salvadori†. Colombia: National University of Colombia CA Alvarez- Moreno*; Ministry of Health ML Mesa Rubio†. Egypt: National Hepatology and Tropical Medicine Research Institute M Hassany*; Ministry of Health and population H Zaid†. Finland: Helsinki University Hospital and South Karelian Central Hospital, Lappeenranta KAO Tikkinen*; Finnish Institute for Health and Welfare and University of Finland, Helsinki M Perola†. France: Hospices Civils de Lyon, Lyon F Ader*§; Institut National de la Santé Et de la Recherche Médicale, Paris MP Kieny†‡§. Honduras: National Autonomous University of Honduras MT Medina*; Secretaria de Salud de Honduras N Cerrato†. India: ICMR National AIDS Research Institute, Pune S Godbole*†; Public Health Foundation of India KS Reddy‡. Indonesia: National Institute of Health Research and Development I Irmansyah*; RSUP Persahabatan, Jakarta MR Rasmin†. Iran (Islamic Republic of): Digestive Disease Research Institute, Teheran University of Medical Sciences, Tehran R Malekzadeh*†‡. Ireland: HRB Clinical Research Facility, University College, Cork J Eustace*; Department of Health T Maguire†. Italy: University of Verona E Tacconelli*; Italian Medicines Agency N Magrini†. Kuwait: Infectious Diseases Hospital A Alhasawi*; Ministry of Health A Al-Bader†. Lebanon: Rafic Hariri University Hospital P Abi Hanna*; Ministry of Public Health R Hamra†. Luxembourg:§. Lithuania: University Hospital Santaros klinikos, Vilnius L Jancoriene*, L Griskevicius†. Malaysia: Penang Hospital TS Chow*; Hospital Sungai Buloh, Jalan Hospital S Kumar†. North Macedonia: University Clinic of Infectious Diseases and Febrile Conditions M Stevanovikj*; Ministry of Health S Manevska†. Norway: Oslo University Hospital P Aukrust*, A Barratt-Due†; Research Council of Norway JA Røttingen‡. Pakistan: Shaukat Khanum Memorial Cancer..
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Late treatment
is less effective
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