dc.date.accessioned2021-04-13T20:50:57Z
dc.date.available2021-04-13T20:50:57Z
dc.date.created2021-04-13T20:50:57Z
dc.date.issued2020
dc.identifierhttps://hdl.handle.net/20.500.12866/9103
dc.identifierhttps://doi.org/10.1056/NEJMoa2023184
dc.description.abstractBACKGROUND: 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.
dc.languageeng
dc.publisherMassachusetts Medical Society
dc.relationNew England Journal of Medicine
dc.relation1533-4406
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectAdenosine Monophosphate
dc.subjectadenosine phosphate
dc.subjectadult
dc.subjectaged
dc.subjectAged
dc.subjectalanine
dc.subjectAlanine
dc.subjectAntiviral Agents
dc.subjectantivirus agent
dc.subjectArticle
dc.subjectartificial ventilation
dc.subjectbeta1a interferon
dc.subjectclinical trial
dc.subjectcombination drug therapy
dc.subjectcomparative study
dc.subjectcontrolled study
dc.subjectcoronavirus disease 2019
dc.subjectCOVID-19
dc.subjectdeath
dc.subjectdrug clearance
dc.subjectdrug repositioning
dc.subjectdrug therapy
dc.subjectDrug Therapy, Combination
dc.subjectdrug withdrawal
dc.subjectextracorporeal oxygenation
dc.subjectfemale
dc.subjectFemale
dc.subjecthealth care quality
dc.subjecthospital mortality
dc.subjectHospital Mortality
dc.subjecthospital patient
dc.subjecthospitalization
dc.subjectHospitalization
dc.subjecthuman
dc.subjectHumans
dc.subjecthydroxychloroquine
dc.subjectHydroxychloroquine
dc.subjectintention to treat analysis
dc.subjectIntention to Treat Analysis
dc.subjectInterferon beta-1a
dc.subjectKaplan Meier method
dc.subjectKaplan-Meier Estimate
dc.subjectlength of stay
dc.subjectLength of Stay
dc.subjectlopinavir
dc.subjectLopinavir
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectMale
dc.subjectmiddle aged
dc.subjectMiddle Aged
dc.subjectmortality
dc.subjectmulticenter study
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectremdesivir
dc.subjectRespiration, Artificial
dc.subjectritonavir
dc.subjecttreatment duration
dc.subjecttreatment failure
dc.subjectTreatment Failure
dc.subjectWorld Health Organization
dc.subjectAdenosine Monophosphate/*analogs & derivatives/therapeutic use
dc.subjectAlanine/*analogs & derivatives/therapeutic use
dc.subjectAntiviral Agents/administration & dosage/adverse effects/*therapeutic use
dc.subjectCOVID-19/*drug therapy/mortality
dc.subjectHydroxychloroquine/*therapeutic use
dc.subjectInterferon beta-1a/*therapeutic use
dc.subjectLopinavir/*therapeutic use
dc.titleRepurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results
dc.typeinfo:eu-repo/semantics/article


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