Remdesivir for Covid-19 — Final Report In this randomized, double-blind trial in 1062 adults hospitalized with Covid-19, remdesivir was superior to placebo in shortening the time to recovery … The trial was sponsored and primarily funded by the NIAID, National Institutes of Health (NIH), Bethesda, MD. The initial length of hospital stay was shorter in the remdesivir group than in the placebo group (median, 12 days vs. 17 days); 5% of patients in the remdesivir group were readmitted to the hospital, as compared with 3% in the placebo group. In hospitalized patients with severe COVID-19, the antiviral drug remdesivir reduced recovery time by about one-third, a large, multinational trial has found. Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). * P values and confidence intervals have not been adjusted for multiple comparisons. enrolled 237 patients (158 assigned to remdesivir and 79 to placebo) in China early in the pandemic and showed a shorter time to improvement (a two-point improvement) with remdesivir: 21.0 days (95% CI, 13.0 to 28.0) in the remdesivir group and 23.0 days (95% CI, 15.0 to 28.0) in the placebo group (hazard ratio for clinical improvement, 1.23; 95% CI, 0.87 to 1.75).14 That trial did not complete full enrollment owing to local control of the outbreak, had lower power than ACTT-1 owing to the smaller sample size and a 2:1 randomization, and was unable to demonstrate any statistically significant clinical benefits of remdesivir. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. (See the protocol for more information about the trial methods.) Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (Covid-19–related or otherwise), 5. Dr. Chu reports receiving consulting fees from Merck and GlaxoSmithKline, grant support from Sanofi Pasteur, and research supplies from Cepheid, Ellume, and Genentech; Dr. Luetkemeyer, receiving grant support, paid to the University of California, San Francisco, from Gilead; Dr. Paredes, receiving grant support and advisory fees from Gilead Sciences, Merck Sharp and Dohme, and ViiV Healthcare; Dr. Touloumi, receiving grant support from Gilead Sciences Europe; Dr. Benfield, receiving grant support from Pfizer, Novo Nordisk Foundation, Simonsen Foundation, and Lundbeck Foundation, grant support and advisory board fees from GlaxoSmithKline, grant support and lecture fees from Pfizer, teaching fees from Boehringer Ingelheim, grant support and teaching fees from Gilead, and teaching fees and advisory board fees from Merck Sharp and Dohme; Dr. Fätkenheuer, receiving grant support, advisory board fees, and travel support from Gilead Sciences and Janssen and grant support and advisory board fees from Merck Sharp and Dohme and ViiV Healthcare; Dr. Kortepeter, receiving consulting fees and serving on a board for Integrum Scientific; Dr. Pett, receiving grant support from Gilead Sciences and ViiV Healthcare; and Dr. Osinusi, being employed by Gilead Sciences. Spinner CD, Gottlieb RL, Criner GJ, et al. ); Seoul National University Hospital, Seoul, South Korea (M.O. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. The benefit in recovery persisted when adjustment was made for glucocorticoid use, which suggests that the benefit of dexamethasone as shown in the Randomized Evaluation of Covid-19 Therapy (RECOVERY) trial4 may be additive to that of remdesivir. The WHO trial evaluated four potential medications for Covid-19, including remdesivir and hydroxychloroquine. Effect of high vs low doses of chloroquine diphosphate as adjunctive therapy for patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: a randomized clinical trial. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059). Treatment with remdesivir was associated with fewer days of subsequent oxygen use for patients receiving oxygen at enrollment and shorter subsequent duration of mechanical ventilation or ECMO for those receiving these interventions at enrollment. Scores on the ordinal scale are as follows: 1, not hospitalized, no limitations of activities; 2, not hospitalized, limitation of activities, home oxygen requirement, or both; 3, hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control reasons); 4, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (Covid-19–related or other medical conditions); 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 8, death. 6. |   Get the latest research information from NIH. Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days. 8. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level. Although changes in the primary outcome are not common in trials for diseases that are well understood, it is recognized that in some trials, such as those involving poorly understood diseases, circumstances may require a change in the way an outcome is assessed or may necessitate a different outcome.16 The original primary outcome became the key secondary end point. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. /total no. A randomized clinical trial involving more than 1000 patients showed that Remdesivir can Block the replication of the virus thus enabling a faster recovery in patients. Table 1. The COVID-19 pandemic: a comprehensive review of taxonomy, genetics, epidemiology, diagnosis, treatment, and control. Below is the status of each of the trial, including one with Roche’s Actemra. 16. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. Recovery rate ratios greater than 1 indicate a benefit with remdesivir; hazard ratios less than 1 indicate a benefit with remdesivir. April 30, 2020 Andre Kalil, M.D. The full table of baseline characteristics is available in the Supplementary Appendix. Written informed consent (or consent by other institutional review board-approved process) was obtained from each patient or from the patient’s legally authorized representative if the patient was unable to provide consent. Among the 913 patients receiving oxygen at enrollment, those in the remdesivir group continued to receive oxygen for fewer days than patients in the placebo group (median, 13 days vs. 21 days), and the incidence of new oxygen use among patients who were not receiving oxygen at enrollment was lower in the remdesivir group than in the placebo group (incidence, 36% [95% CI, 26 to 47] vs. 44% [95% CI, 33 to 57]). Royal College of Physicians. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. the latest public health information from CDC, Autoimmune Lymphoproliferative Syndrome (ALPS), Characterizing Food Allergy & Addressing Related Disorders, Prevention, Treatment & Control Strategies, Strategic Partnerships & Research Capacity, Primary Immune Deficiency Diseases (PIDDs), Partnership for Access to Clinical Trials (PACT), Division of Allergy, Immunology, and Transplantation, Division of Microbiology and Infectious Diseases, Dr. Joseph Kinyoun The Indispensable Forgotten Man, Dr. Joseph Kinyoun: Selected Bibliography, Gene Therapy Restores Immune Function in Children with Rare Immunodeficiency, Trial of Existing Antibiotic for Treating Staphylococcus aureus Bacteremia Begins, National Institute of Allergy and Infectious Diseases (NIAID), has shown promise in animal models for treating SARS-CoV-2 (the virus that causes COVID-19) infection, NIH Clinical Trial Testing Antiviral Remdesivir Plus Anti-Inflammatory Drug Baricitinib for COVID-19 Begins, NIH Clinical Trial of Remdesivir to Treat COVID-19 Begins, NIH Clinical Trial Testing Remdesivir Plus Interferon Beta-1a for COVID-19 Treatment Begins, Experimental MERS Treatments Enter Clinical Trial, Peer-Reviewed Data Shows Remdesivir for COVID-19 Improves Time to Recovery, Modeling Immunity for Biodefense Summer School and Symposium. The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. Sheahan TP, Sims AC, Leist SR, et al. Information on interactions of treatment with baseline ordinal score with respect to mortality is provided in Table S11. In this double-blind, randomized, placebo-controlled trial (ACTT-2; ClinicalTrials.gov … The change was proposed on March 22, 2020 (after 72 patients had been enrolled), by trial statisticians who were unaware of treatment assignments and had no knowledge of outcome data. The trial was implemented during a time of restricted travel, and hospitals restricted the entrance of nonessential personnel. ), University of California, San Diego, La Jolla (D.A.S. ); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.). A normal saline placebo was used at the European sites and at some non-European sites owing to a shortage of matching placebo; for these sites, the remdesivir and placebo infusions were masked with an opaque bag and tubing covers to maintain blinding. The primary outcome was initially a comparison of clinical status at day 15 on the eight-category ordinal scale. This should not be interpreted as conclusively showing a lack of efficacy in higher ordinal score categories. 3. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Borba MGS, Val FFA, Sampaio VS, et al. Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Helmy YA, Fawzy M, Elaswad A, Sobieh A, Kenney SP, Shehata AA.   Patients in the remdesivir group had a shorter time to improvement of one or of two categories on the ordinal scale from baseline than patients in the placebo group (one-category improvement: median, 7 vs. 9 days; rate ratio for recovery, 1.23; 95% CI, 1.08 to 1.41; two-category improvement: median, 11 vs. 14 days; rate ratio, 1.29; 95% CI, 1.12 to 1.48) (Table 3). Baricitinib and remdesivir combination therapy was superior to remdesivir alone in reducing recovery time and accelerating clinical status improvement in patients with coronavirus disease 2019 (COVID-19), according to results published in The New England Journal of Medicine.. The RECOVERY Collaborative Group. The trial showed that patients taking remdesivir had a shorter time to recovery at 11 days, while patients taking a placebo recovered in 15 days, according to Fauci. The initial length of hospital stay was shorter in the remdesivir group than in the placebo group (median, 12 days vs. 17 days); 5% of patients in the remdesivir group were readmitted to the hospital, as compared with 3% in the placebo group. 15. The RECOVERY Trial is currently testing some of these suggested treatments: Regeneron’s antibody cocktail (a combination of monoclonal antibodies directed against coronavirus) Baricitinib (an immunomodulatory drug used in rheumatoid arthritis) Dimethyl fumarate (an immunomodulatory drug used in psoriasis and multiple sclerosis). The CONSORT Group. The authorized source of trusted medical research and education for the Chinese-language medical community. JAMA Netw Open 2020;3(4):e208857-e208857. The median recovery time for patients in category 7 could not be estimated, which suggests that the follow-up time may have been too short to evaluate that subgroup. Eleven patients (1.0%) had missing ordinal scale data at enrollment; all these patients discontinued the study before treatment. Training, site initiation visits, and monitoring visits often were performed remotely. N Engl J Med. Wang M, Cao R, Zhang L, et al. Sensitivity analyses in which data were censored at earliest reported use of glucocorticoids or hydroxychloroquine still showed efficacy of remdesivir (9.0 days to recovery with remdesivir vs. 14.0 days to recovery with placebo; rate ratio, 1.28; 95% CI, 1.09 to 1.50, and 10.0 vs. 16.0 days to recovery; rate ratio, 1.32; 95% CI, 1.11 to 1.58, respectively) (Table S8). The trial protocol was approved by the institutional review board at each site (or by a centralized institutional review board as applicable) and was overseen by an independent data and safety monitoring board. Hospitalized, requiring supplemental oxygen, 6. Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). In the recently published, open-label, randomized study of remdesivir in hospitalized patients with moderate-severity Covid-19 (83% were not receiving oxygen at baseline), patients who received remdesivir for 5 days had higher odds of clinical improvement than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09 to 2.48; P=0.02). However, the primary outcome was changed to a comparison of time to recovery by day 29 in response to evolving information, external to the trial, indicating that Covid-19 may have a more protracted course than previously anticipated. The primary outcome was the time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient met the criteria for category 1, 2, or 3 on the eight-category ordinal scale. (See the full description of trial procedures in the Supplementary Appendix, available at NEJM.org.). The US National Institutes of Health-sponsored Adaptive COVID-19 Treatment Trial (ACTT-1) compared remdesivir with placebo among 1063 Results are being released early after a review by independent experts overseeing the trial's safety and conduct … A total of 957 patients (90.1%) had severe disease at enrollment; 285 patients (26.8%) met category 7 criteria on the ordinal scale, 193 (18.2%) category 6, 435 (41.0%) category 5, and 138 (13.0%) category 4. These results were subsequently made public. The findings are statistically significant and are based on an analysis of 1059 participants (538 who received remdesivir and 521 who received placebo). At the time of the data and safety monitoring board report, which was based on data cutoff date of April 22, 2020, a total of 482 recoveries (exceeding the estimated number of recoveries needed for the trial) and 81 deaths had been entered in the database. Patients were considered to have severe disease if they required mechanical ventilation, if they required supplemental oxygen, if the oxygen saturation as measured by pulse oximetry (Spo2) was 94% or lower while they were breathing ambient air, or if they had tachypnea (respiratory rate ≥24 breaths per minute). A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Open Forum Infect Dis 2019;6:ofz137-ofz137. Data entry must be … For time-to-recovery and time-to-improvement analyses, data for patients who did not recover and data for patients who died were censored at day 29. The double-blind trial involved 1,063 patients who underwent randomization to either receive remdesivir intravenously or a placebo. Lancet 2020;395:1569-1578. Editor’s Note: A preliminary version of this article was published on May 22, 2020, at NEJM.org. Sci Transl Med 2017;9:eaal3653-eaal3653. Broad spectrum antiviral remdesivir inhibits human endemic and zoonotic deltacoronaviruses with a highly divergent RNA dependent RNA polymerase. ), University of California, Irvine, Irvine (L.H. Hospitalized, receiving noninvasive ventilation or high-flow oxygen devices, 7. Hospitalized, receiving invasive mechanical ventilation or ECMO, Hazard ratio for data through day 15 (95% CI), Kaplan–Meier estimate of mortality by day 15 — % (95% CI), Kaplan–Meier estimate of mortality by day 29 — % (95% CI), Improvement of one category on ordinal scale, Improvement of two categories on ordinal scale, Discharge or National Early Warning Score ≤2 for 24 hr, Median duration of initial hospitalization (IQR) — days, Median duration of initial hospitalization among those who did not die (IQR) — days, Median days receiving oxygen if receiving oxygen at baseline (IQR), Median days of noninvasive ventilation or high-flow oxygen use during study if receiving these interventions at baseline (IQR), New use of new noninvasive ventilation or high-flow oxygen use during the study, Median days of use during the study (IQR), Median days of mechanical ventilation or ECMO during study if receiving these interventions at baseline (IQR), New use of mechanical ventilation or ECMO during study. Many sites did not have adequate supplies of personal protective equipment and trial-related supplies, such as swabs. Cell Res 2020;30:269-271. Sheahan TP, Sims AC, Graham RL, et al. An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. An interim analysis by the independent data and safety monitoring board (DSMB) found that remdesivir performed better on the primary endpoint of ‘time to recovery’ when compared to placebo. A separate NIH animal study found that early treatment with remdesivir significantly reduced clinical disease and lung … Additional secondary end points supporting these findings include remdesivir treatment resulting in a shorter time to improvement of one and of two ordinal scale categories, a shorter time to discharge or to a sustained National Early Warning Score of 2 or lower, and a shorter length of initial hospital stay (median, 12 days vs. 17 days). A clinical trial by the US National Institutes of Health found that hospitalised patients with advanced COVID-19 and lung involvement who received remdesivir recovered 31% faster and had better survival than those treated with a placebo. § The ordinal score at day 15 is the patient’s worst score on the ordinal scale during the previous day. 7. Researchers are now testing remdesivir in combination with antibodies and other medications. ); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P. Only the 1000 most recent citing articles are listed here. ), and Baylor College of Medicine, Houston (R.L.A. The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12) (Table S2). Remdesivir has also received full or conditional approval in several other countries since that time. 2017 (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). 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