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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 5% Improvement Relative Risk Non-ventilated patients 14% Remdesivir  SOLIDARITY  LATE TREATMENT  RCT Is late treatment with remdesivir beneficial for COVID-19? RCT 5,451 patients in multiple countries No significant difference in mortality c19early.org SOLIDARITY Trial Consortium, NEJM, Oct 2020 Favorsremdesivir Favorscontrol 0 0.5 1 1.5 2+
WHO SOLIDARITY open-label RCT with 2,750 very late stage (76% on oxygen/ventilation) remdesivir patients, mortality relative risk RR 0.95 [0.81-1.11], p=0.50. Non-ventilated patients show a greater benefit, RR 0.86 [0.72-1.04], p = 0.13.
Gérard, Zhou, Wu, Kamo, Choi, Kim show significantly increased risk of acute kidney injury with remdesivir.
Remdesivir efficacy disappears with longer followup. Mixed-effects meta-regression of efficacy as a function of followup duration across all remdesivir studies shows decreasing efficacy with longer followup7. This may reflect antiviral efficacy being offset by serious adverse effects of treatment.
Followup duration (days) Efficacy Remdesivir mortality efficacy decreases with longer followup 0 15 30 45 60 75 90 105 -25% 0% 25% 50% c19early.org December 2024 mixed-effects meta-regression slope -0.58 [95% CI -0.92 to -0.24] p=0.00089
Study covers remdesivir and HCQ.
risk of death, 5.0% lower, RR 0.95, p = 0.53, treatment 301 of 2,743 (11.0%), control 303 of 2,708 (11.2%), NNT 464, day 28.
non-ventilated patients, 14.0% lower, RR 0.86, p = 0.13, day 28.
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, 15 authors, trial NCT04315948 (history) (SOLIDARITY).
This PaperRemdesivirAll
Abstract: new england journal of medicine The February 11, 2021 established in 1812 vol. 384 no. 6 Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results WHO Solidarity Trial Consortium*​​ a bs t r ac t BACKGROUND World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS 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). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.) n engl j med 384;6 nejm.org The members of the writing and steering committees (H. Pan, R. Peto, A.-M. Henao‑Restrepo, M.-P. Preziosi, V. Sathiyamoorthy, Q. Abdool Karim, M.M. Alejandria, C. Hernández García, M.-P. Kieny, R. Malekzadeh, S. Murthy, K.S. Reddy, M. Roses Periago, P. Abi Hanna, F. Ader, A.M. Al‑Bader, A. Alhasawi, E. Allum, A. Alotaibi, C.A. Alvarez‑Moreno, S. Appadoo, A. Asiri, P. Aukrust, A. Barratt‑Due, S. Bellani, M. Branca, H.B.C. Cappel‑Porter, N. Cerrato, T.S. Chow, N. Como, J. Eustace, P.J. García, S. Godbole, E. Gotuzzo, L. Griskevicius, R. Hamra, M. Hassan, M. Hassany, D. Hutton, I. Irmansyah, L. Jancoriene, J. Kirwan, S. Kumar, P. Lennon, G. Lopardo, P. Lydon, N. Magrini, T. Maguire, S. Manevska, O. Manuel, S. McGinty, M.T. Medina, M.L. Mesa..
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Late treatment
is less effective
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