essai recovery nejm
The members of the writing and steering committees are as follows: Hongchao Pan, Ph.D., Richard Peto, F.R.S., Ana-Maria Henao-Restrepo, M.D., Marie-Pierre Preziosi, Ph.D., Vasee Sathiyamoorthy, Ph.D., Quarraisha Abdool Karim, Ph.D., Marissa M. Alejandria, M.D., César Hernández García, Ph.D., Marie-Paule Kieny, Ph.D., Reza Malekzadeh, M.D., Srinivas Murthy, M.D., K. Srinath Reddy, M.D., Mirta Roses Periago, M.D., Pierre Abi Hanna, M.D., Florence Ader, Ph.D., Abdullah M. Al-Bader, Ph.D., Almonther Alhasawi, M.D., Emma Allum, M.Math., Athari Alotaibi, M.Sc., Carlos A. Alvarez-Moreno, Ph.D., Sheila Appadoo, M.P.H., Abdullah Asiri, M.B., B.S., Pål Aukrust, Ph.D., Andreas Barratt-Due, Ph.D., Samir Bellani, B.Sc., Mattia Branca, Ph.D., Heike B.C. There were 1253 in-hospital deaths (the primary outcome, including those before and after day 28). † Among the women, 2 in the hydroxychloroquine group and 4 in the usual-care group were pregnant. Mahévas M, Tran V-T, Roumier M, et al. Table 1. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEJM Knowledge+ Pain Management and Opioids (FM) only This Enduring Material activity, NEJM Knowledge+ Pain Management and Opioids, has been reviewed and is acceptable for up to 10.00 Prescribed credit(s) by the American Academy of Family Physicians. On June 4, 2020, in response to a request from the MHRA, the independent data monitoring committee conducted a review of the data and recommended that the chief investigators review the unblinded data for the hydroxychloroquine group. Summation of these trial-specific observed-minus-expected subtotals then led to an appropriately weighted average of the results from all trials, which yielded a rate ratio for death (remdesivir vs. control) of 0.91 (95% CI, 0.79 to 1.05).5 Figures S19 and S20 show the mortality results in the trials of hydroxychloroquine (rate ratio, 1.09; 95% CI, 0.98 to 1.21) and of lopinavir (rate ratio, 1.01; 95% CI, 0.91 to 1.13). — both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T. ), the School of Life Course Sciences, King’s College London (L.C.C. Investigators were advised that any patients who were receiving hydroxychloroquine as part of the trial should discontinue the treatment. The Purdue Pharma Opioid Settlement — Accountability, or Just the Cost of Doing Business? DOI: 10.1056/NEJMoa2023184, Tap into groundbreaking research and clinically relevant insights. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. The full database is held by the trial team, which collected the data from the trial sites and performed the analyses, at the Nuffield Department of Population Health at the University of Oxford. Denominators for the few deaths on day 0, but not on later days, included patients with no follow-up reported (because if any patient died on the day of randomization, this would probably have been reported). Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results. Interpretation of this should chiefly reflect not the P value (P=0.20) or point estimate (rate ratio, 0.91) but the confidence interval (0.79 to 1.05), which shows the range of rate ratios for death that are compatible with the weighted average of the findings from all trials. The frequency of use of azithromycin or other macrolide drug during the follow-up period was similar in the hydroxychloroquine group and the usual-care group (18.6% vs. 20.3%), as was the use of dexamethasone (9.1% vs. 9.2%). Hence, there was partial overlap among the four control groups. — both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G. Tocilizumab was provided free of charge for this study by Roche. Rate Ratios for In-Hospital Death, Subdivided by Age and Respiratory Support at Trial Entry. No evidence of rapid antiviral clearance or clinical benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection. Treating COVID-19 with chloroquine. Conclusion : l'HCQ n'a pas d'effet sur la mortalité des patients covid19. This article was published on October 8, 2020, at NEJM.org. The size of the squares representing rate ratios is proportional to the amount of statistical information that was available for each comparison. ); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) 26. Although assignment to any of the active trial treatments in this open-label trial somewhat delayed discharge from the hospital, this could have been because some recovered patients otherwise fit for discharge were kept in the hospital merely to continue their trial treatment. Br J Cancer 2011;104:1057-1058. 10. For hydroxychloroquine, the joint rate ratio for death (combining the Solidarity and RECOVERY trials) was 1.10 (95% CI, 0.98 to 1.23), with no apparent benefit whether the patient was receiving ventilation or not. No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. The WHO has released preliminary results from the SOLIDARITY trial on the effectiveness of hydroxychloroquine in hospitalized patients with Covid-19 that are consistent with the results from the RECOVERY trial.40. 6. Use of these drugs is premature and potentially harmful The BMJ in 1925 cautiously endorsed Moellgaard’s gold treatment for tuberculosis,1 although it found his pharmacological reasoning “both interesting and instructive.”2 We should be similarly cautious about proposed treatments for people infected with SARS-CoV-2, the virus that causes covid-19. After oral administration, they are rapidly absorbed, even in severely ill patients. The supplementary analyses (Tables S2 and S3) tabulate co-medication (only small absolute differences were found between each trial drug and its control) and provide a multivariable Cox regression fitting all four treatment effects simultaneously (rate ratios for death were similar to those in Figure 3). 33. BMJ 2020;369:m1844-m1844. Similarly, for other drugs adherence midway was 94% to 95%, and crossover was 2 to 6%. ), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W. We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). In addition, 6 patients were randomly assigned to receive either convalescent plasma or usual care alone (1 patient [0.1%] in the hydroxychloroquine group and 5 patients [0.2%] in the usual-care group) in accordance with protocol version 6.0. For interferon beta-1a, no other large trials exist. Editor’s Note: This article was published on June 3, 2020, at NEJM.org. The RECOVERY trial is an investigator-initiated platform trial to evaluate the effects of potential treatments in patients hospitalized with Covid-19. White NJ, Watson JA, Hoglund RM, Chan XHS, Cheah PY, Tarning J. COVID-19 prevention and treatment: a critical analysis of chloroquine and hydroxychloroquine clinical pharmacology. Mental Health and the Covid-19 Pandemic Many aspects of the Covid-19 pandemic and the public health response to it will undoubtedly contribute to … The chief investigators and steering committee members concluded that the data showed no beneficial effect of hydroxychloroquine in patients hospitalized with Covid-19. The variance that is attributed to the result in each stratum and to the overall weighted average reflects only the play of chance at randomization. Graphs of mortality according to time are from unstratified Kaplan–Meier methods, with denominators chosen to yield in-hospital mortality. S6 through S9). Reges, M.D., Chris A. Rogers, Ph.D., Kolawole Salami, M.D., Marina I. Salvadori, M.D., Narvina Sinani, Pharm.D., Jonathan A.C. Sterne, Ph.D., Milena Stevanovikj, Ph.D., Evelina Tacconelli, Ph.D., Kari A.O. The only protocol-specified secondary outcomes were the initiation of mechanical ventilation and hospitalization duration. Hydroxychloroquine causes predictable prolongation of the corrected QT interval on electrocardiography, which is exacerbated by coadministration with azithromycin, as widely prescribed in Covid-19 treatment.16-18 Although torsades de pointes has been described, serious cardiovascular toxicity has been infrequently reported, despite the high prevalence of cardiovascular disease in hospitalized patients, the common occurrence of myocarditis in Covid-19, and the extensive use of hydroxychloroquine and azithromycin together. ‖ Countries included Argentina, Brazil, Colombia, Honduras, and Peru. Table 1 shows patient characteristics: 9120 (81%) were younger than 70 years of age, 6985 (62%) were male, 2768 (25%) had diabetes, 916 (8%) were already receiving ventilation, and 7002 (62%) underwent randomization on days 0 or 1. BMJ 2020;369:m1849-m1849. This is the New England Journal of Medicine version of record, which includes all Journal editing and enhancements. In this open-label trial, no placebos were used. Horby, Mafham, and Linsell and Prof. Juszczak, Dr. Haynes, and Dr. Landray contributed equally to this article. 3. ), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (Covid-19), emerged in China in late 2019 from a zoonotic source.1 The majority of Covid-19 infections are either asymptomatic or result in only mild disease. The protocol-specified primary objective was to assess effects on in-hospital mortality (i.e., death during the original hospitalization; follow-up ceased at discharge), regardless of whether death occurred before or after day 28. Sci China Life Sci 2020 May 15 (Epub ahead of print). Remdesivir for the treatment of Covid-19 — final report. Int J Antimicrob Agents 2020;56:105949-105949. The exception is a Brazilian study that was stopped early because of cardiotoxicity. Other grants are listed in the Supplementary Appendix. Duration of Culturable SARS-CoV-2 in Hospitalized Patients with Covid-19, Last-Mile Logistics of Covid Vaccination — The Role of Health Care Organizations, Case 3-2021: A 48-Year-Old Man with Transient Vision Loss, Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation, https://www.who.int/blueprint/priority-diseases/key-action/Coronavirus_Roadmap_V9.pdf?ua=1, https://www.who.int/teams/blueprint/covid-19, https://www.who.int/publications/m/item/an-international-randomised-trial-of-additional-treatments-for-covid-19-in-hospitalised-patients-who-are-all-receiving-the-local-standard-of-care, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf, https://www.medrxiv.org/content/10.1101/2020.09.16.20194571v2, https://apps.who.int/iris/handle/10665/334125, Percent taking trial drug midway through scheduled duration, Percent ever reported as discharged who were still in the hospital at various times. Prespecified analyses of the primary outcome were performed in six subgroups, as defined by characteristics at randomization: age, sex, race, level of respiratory support, days since symptom onset, and predicted 28-day risk of death. The risk on day N was calculated by first excluding patients with an outcome not reported or an entry fewer than N days before data-set closure (or transferred elsewhere before day N); then, the number of in-hospital deaths on day N was divided by the total number of patients in the hospital on day N or discharged alive before day N. This denominator (or “risk set”), which includes those discharged before day N, was also used to calculate the contribution of day N to log-rank analysis and Cox analysis of in-hospital mortality. ), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L. All 3 patients for whom the diagnosis of Covid-19 was later ruled out were included in the analyses and survived. Biochem Biophys Res Commun 2004;323:264-268. 3. 31. Tang W, Cao Z, Han M, et al. J Mol Cell Biol 2020;12:322-325. A complete list of collaborators in the RECOVERY trial is provided in the Supplementary Appendix, available at NEJM.org. The number of patients who were assigned to receive usual care was twice the number who were assigned to any of the active treatments for which the patient was eligible (e.g., 2:1 ratio in favor of usual care if the patient was eligible for only one active treatment group, 2:1:1 if the patient was eligible for two active treatments, etc.). Therefore, the enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, and the preliminary result for the primary outcome was made public. Verity R, Okell LC, Dorigatti I, et al. Effects of Remdesivir, Hydroxychloroquine, Lopinavir, and Interferon on In-Hospital Mortality. World Health Organization. Lancet Infect Dis 2020;20:669-677. ), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L. Caring for Ms. L. Like a swimmer pulled into the undertow, Ms. L. had been dragged back into the cold, dark brine of addiction. Lopinavir-ritonavir in patients admitted to hospital with Covid-19 (RECOVERY): a randomised, controlled, open-label, platform trial.
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