Repurposed antiviral drugs for Covid-19 - Interim WHO Solidarity Trial results

Simple item page
dc.check.date2021-06-02
dc.check.infoAccess to this article is restricted until 6 months after publication by request of the publisher.en
dc.contributor.authorPan, H.
dc.contributor.authorPeto, R.
dc.contributor.authorHenao-Restrepo, A. M.
dc.contributor.authorPreziosi, M. P.
dc.contributor.authorSathiyamoorthy, V.
dc.contributor.authorAbdool Karim, Q.
dc.contributor.authorAlejandria, M. M.
dc.contributor.authorHernández Garcí­a, C.
dc.contributor.authorKieny, M.P.
dc.contributor.authorMalekzadeh, R.
dc.contributor.authorMurthy, S.
dc.contributor.authorReddy, K. S.
dc.contributor.authorRoses Periago, M.
dc.contributor.authorAbi Hanna, P.
dc.contributor.authorAder, F.
dc.contributor.authorAl-Bader, A. M.
dc.contributor.authorAlhasawi, A.
dc.contributor.authorAllum, E.
dc.contributor.authorAlotaibi, A.
dc.contributor.authorAlvarez-Moreno, C. A.
dc.contributor.authorAppadoo, S.
dc.contributor.authorAsiri, A.
dc.contributor.authorAukrust, P.
dc.contributor.authorBarratt-Due, A.
dc.contributor.authorBellani, S.
dc.contributor.authorBranca, M.
dc.contributor.authorCappel-Porter, H. B. C
dc.contributor.authorCerrato, N.
dc.contributor.authorChow, T. S.
dc.contributor.authorComo, N.
dc.contributor.authorEustace, Joseph A.
dc.contributor.authorGarcí­a, P. J.
dc.contributor.authorGodbole, S.
dc.contributor.authorGotuzzo, E.
dc.contributor.authorGriskevicius, L.
dc.contributor.authorHamra, R.
dc.contributor.authorHassan, M.
dc.contributor.authorHassany, M.
dc.contributor.authorHutton, D.
dc.contributor.authorIrmansyah, I.
dc.contributor.authorJancoriene, L.
dc.contributor.authorKirwan, J.
dc.contributor.authorKumar, S.
dc.contributor.authorLennon, P.
dc.contributor.authorLopardo, G.
dc.contributor.authorLydon, P.
dc.contributor.authorMagrini, N.
dc.contributor.authorMaguire, T.
dc.contributor.authorManevska, S.
dc.contributor.authorManuel, O.
dc.contributor.authorMcGinty, S.
dc.contributor.authorMedina, M. T.
dc.contributor.authorMesa Rubio, M. L.
dc.contributor.authorMiranda-Montoya, M. C.
dc.contributor.authorNel, J.
dc.contributor.authorNunes, E. P.
dc.contributor.authorPerola, M.
dc.contributor.authorPortolés, A.
dc.contributor.authorRasmin, M. R.
dc.contributor.authorRaza, A.
dc.contributor.authorRees, H.
dc.contributor.authorReges, P. P. S.
dc.contributor.authorRogers, C. A.
dc.contributor.authorSalami, K.
dc.contributor.authorSalvadori, M. I.
dc.contributor.authorSinani, N.
dc.contributor.authorSterne, J. A. C.
dc.contributor.authorStevanovikj, M.
dc.contributor.authorTacconelli, E.
dc.contributor.authorTikkinen, K. A. O.
dc.contributor.authorTrelle, S.
dc.contributor.authorZaid, H.
dc.contributor.authorRøttingen, J. A.
dc.contributor.authorSwaminathan, S.
dc.contributor.funderWorld Health Organizationen
dc.date.accessioned2021-03-04T12:56:13Z
dc.date.available2021-03-04T12:56:13Z
dc.date.issued2020-12-02
dc.date.updated2021-03-04T12:40:20Z
dc.description.abstractBackground: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs â remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a â 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 Kaplanâ 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.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationPan, H., Peto, R., Henao-Restrepo, A. M., Preziosi, M. P., Sathiyamoorthy, V., Abdool Karim, Q., Alejandria, M. M., Hernández García, C., Kieny, M.P., Malekzadeh, R., Murthy, S., Reddy, K. S., Roses Periago, M., Abi Hanna, P., Ader, F., Al-Bader, A. M., Alhasawi, A., Allum, E., Alotaibi, A., Alvarez-Moreno, C. A., Appadoo, S., Asiri, A., Aukrust, P., Barratt-Due, A., Bellani, S., Branca, M., Cappel-Porter, H. B. C, Cerrato, N., Chow, T. S., Como, N., Eustace, J., García, P. J., Godbole, S., Gotuzzo, E., Griskevicius, L., Hamra, R., Hassan, M., Hassany, M., Hutton, D., Irmansyah, I., Jancoriene, L., Kirwan, J., Kumar, S., Lennon, P., Lopardo, G., Lydon, P., Magrini, N., Maguire, T., Manevska, S., Manuel, O., McGinty, S., Medina, M. T., Mesa Rubio, M. L., Miranda-Montoya, M. C., Nel, J., Nunes, E. P., Perola, M., Portolés, A., Rasmin, M. R., Raza, A., Rees, H., Reges, P. P. S., Rogers, C. A., Salami, K., Salvadori, M. I., Sinani, N., Sterne, J. A. C., Stevanovikj, M., Tacconelli, E., Tikkinen, K. A. O., Trelle, S., Zaid, H., Røttingen, J. A. and Swaminathan, S. (2020) 'Repurposed antiviral drugs for Covid-19 - Interim WHO Solidarity Trial results', New England Journal of Medicine, 384(6), pp. 497-511. doi: 10.1056/NEJMoa2023184en
dc.identifier.doi10.1056/NEJMoa2023184en
dc.identifier.eissn1533-4406
dc.identifier.endpage511en
dc.identifier.issn0028-4793
dc.identifier.issued6en
dc.identifier.journaltitleNew England Journal of Medicineen
dc.identifier.startpage497en
dc.identifier.urihttps://hdl.handle.net/10468/11115
dc.identifier.volume384en
dc.language.isoenen
dc.publisherMassachusetts Medical Societyen
dc.relation.urihttps://www.isrctn.com/ISRCTN83971151
dc.relation.urihttps://clinicaltrials.gov/ct2/show/NCT04315948
dc.rights© 2020, Massachusetts Medical Society. All rights reserved.en
dc.subjectRemdesiviren
dc.subjectHydroxychloroquineen
dc.subjectLopinaviren
dc.subjectInterferonen
dc.subjectCovid-19en
dc.subjectMortalityen
dc.subjectInitiation of ventilationen
dc.subjectDuration of hospital stayen
dc.titleRepurposed antiviral drugs for Covid-19 - Interim WHO Solidarity Trial resultsen
dc.typeArticle (peer-reviewed)en
Files
Original bundle
Now showing 1 - 2 of 2
Thumbnail Image
Name:
nejmoa2023184.pdf
Size:
688.53 KB
Format:
Adobe Portable Document Format
Description:
Published Version
Download
Thumbnail Image
Name:
nejmoa2023184_data-sharing.pdf
Size:
70.19 KB
Format:
Adobe Portable Document Format
Description:
Data Sharing Statement
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
HRB Clinical Research Facility at UCC - Journal Articles