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Repurposed Antiviral Drugs for Covid-19 — Interim Who Solidarity Trial Results Publisher Pubmed



Pan H1 ; Peto R1 ; Henaorestrepo AM3 ; Preziosi MP3 ; Sathiyamoorthy V3 ; Karim QA6 ; Alejandria MM9 ; Garcia CH10 ; Kieny MP12 ; Malekzadeh R14 ; Murthy S15 ; Srinath Reddy K17 ; Periago MR19 ; Hanna PA21 Show All Authors
Authors
  1. Pan H1
  2. Peto R1
  3. Henaorestrepo AM3
  4. Preziosi MP3
  5. Sathiyamoorthy V3
  6. Karim QA6
  7. Alejandria MM9
  8. Garcia CH10
  9. Kieny MP12
  10. Malekzadeh R14
  11. Murthy S15
  12. Srinath Reddy K17
  13. Periago MR19
  14. Hanna PA21
  15. Ader F13
  16. Albader AM23
  17. Alhasawi A24
  18. Allum E2
  19. Alotaibi A27
  20. Alvarezmoreno CA25
  21. Appadoo S4
  22. Asiri A27
  23. Aukrust P28
  24. Barrattdue A28
  25. Bellani S2
  26. Branca M4
  27. Cappelporter HBC2
  28. Cerrato N30
  29. Chow TS32
  30. Como N34
  31. Eustace J36
  32. Garcia PJ38
  33. Godbole S18
  34. Gotuzzo E38
  35. Griskevicius L39
  36. Hamra R22
  37. Hassan M41
  38. Hassany M42
  39. Hutton D2
  40. Irmansyah I44
  41. Jancoriene L40
  42. Kirwan J2
  43. Kumar S33
  44. Lennon P37
  45. Lopardo G20
  46. Lydon P3
  47. Magrini N46
  48. Maguire T37
  49. Manevska S48
  50. Manuel O5
  51. Mcginty S4
  52. Medina MT31
  53. Mesa Rubio ML26
  54. Mirandamontoya MC3
  55. Nel J7
  56. Nunes EP50
  57. Perola M51
  58. Portoles A11
  59. Rasmin MR45
  60. Raza A41
  61. Rees H8
  62. Reges PPS50
  63. Rogers CA2
  64. Salami K3
  65. Salvadori MI16
  66. Sinani N35
  67. Sterne JAC2
  68. Stevanovikj M49
  69. Tacconelli E47
  70. Tikkinen KAO52, 53
  71. Trelle S4
  72. Zaid H43
  73. Rottingen JA29
  74. Swaminathan S3

Source: New England Journal of Medicine Published:2021


Abstract

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. Copyright © 2020 Massachusetts Medical Society.
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