King JC, Beigel JH, Ison MG, et al. The Kaplan–Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Little was known about the natural clinical course of Covid-19 when the trial was designed in February 2020. Royal College of Physicians. 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. Seventy patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death and 14 withdrew consent. Some of this difference may be due to the larger sample size in this category since confidence intervals for baseline ordinal scores of 4 (not receiving oxygen), 6 (receiving high-flow oxygen), and 7 (receiving ECMO or mechanical ventilation) were wide. For the 193 patients receiving noninvasive ventilation or high-flow oxygen at enrollment, the median duration of use of these interventions was 6 days in both the remdesivir and placebo groups. — both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C. In hospitalized patients with severe COVID-19, the antiviral drug remdesivir reduced recovery time by about one-third, a large, multinational trial has found. 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. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. 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. Remdesivir has also received full or conditional approval in several other countries since that time. Overall, 53.3% of the patients were White, 21.3% were Black, 12.7% were Asian, and 12.7% were designated as other or not reported; 250 (23.5%) were Hispanic or Latino. (See the Supplementary Appendix for more information about the planned statistical analysis.) The ACTT trial, which involved 1063 hospitalised patients with advanced Covid-19 and lung involvement, compared the experimental antiviral drug to placebo. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. 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. ), and Evergreen Health Medical Center, Kirkland (D.L.C.) After the data and safety monitoring board recommended that the preliminary primary analysis report be provided to the sponsor, data on a total of 51 patients (4.8% of the total study enrollment) — 16 (3.0%) in the remdesivir group and 35 (6.7%) in the placebo group — were unblinded; 26 (74.3%) of those in the placebo group whose data were unblinded were given remdesivir. Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. 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. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. 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. 8. 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 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. (2020, April 29). Editor’s Note: A preliminary version of this article was published on May 22, 2020, at NEJM.org. 16. Odds ratio values greater than 1 indicate a benefit with remdesivir. The findings in our trial should be compared with those observed in other randomized trials of remdesivir. The categories are as follows: 1, not hospitalized and no limitations of activities; 2, not hospitalized, with 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 or other nonmedical reasons); 4, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to 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. Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21. and University of Minnesota School of Public Health and INSIGHT (J.D.N. Support for the London International Coordinating Centre was also provided by the United Kingdom Medical Research Council (MRC_UU_12023/23). * P values and confidence intervals have not been adjusted for multiple comparisons. A pandemic produces record advances—and painful missteps. However, research teams were motivated to find creative solutions to overcome these challenges. Throughout the trial, we were able to enroll a diverse population, similar to the population that was being infected with SARS-CoV-2 during that period. NIH clinical trial shows remdesivir accelerates recovery from advanced COVID-19. Cell Res 2020;30:269-271. Preliminary results were published today in the New England Journal of Medicine. A clinical trial conducted by the National Institute of Health found that the drug remdesivir may help coronavirus patients recover faster. (See the full description of trial procedures in the Supplementary Appendix, available at NEJM.org.). * The National Early Warning Score includes six physiological measures; total scores range from 0 to 20, with higher scores indicating greater clinical risk. Patients who received remdesivir had a shorter time to recovery (the primary end point) than those who received placebo (median, 10 days vs. 15 days; rate ratio for recovery, 1.29 [95% CI, 1.12 to 1.49]) and were more likely to have improvement in the ordinal scale score at day 15 (key secondary end point; odds ratio, 1.5; 95% CI, 1.2 to 1.9). Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level. The primary outcome was initially a comparison of clinical status at day 15 on the eight-category ordinal scale. Table 2. 11. de Wit E, Feldmann F, Cronin J, et al. To evaluate the clinical efficacy and safety of putative investigational therapeutic agents among hospitalized adults with laboratory-confirmed Covid-19, we designed an adaptive platform trial to rapidly conduct a series of phase 3, randomized, double-blind, placebo-controlled trials. In this double-blind, randomized, placebo-controlled trial (ACTT-2; ClinicalTrials.gov … University of Illinois - Chicago's coronavirus Remdesivir drug trial was a godsend for many patients, including one Chicago woman who described her recovery … In the meantime, the RECOVERY trial will continue, with several other arms of the study yet to read out. ); University of Pennsylvania, Philadelphia (W.R.S. In the severe disease stratum (957 patients) the median time to recovery was 11 days, as compared with 18 days (rate ratio for recovery, 1.31; 95% CI, 1.12 to 1.52) (Table S4). Middle East respiratory syndrome coronavirus (MERS-CoV) causes transient lower respiratory tract infection in rhesus macaques. The largest previous trial of remdesivir in covid-19, the ACTT-1 study sponsored by the US National Institutes of Health, found a significant benefit in time to recovery and what remdesivir’s maker, Gilead, called a non-significant trend towards improved survival at 29 days (hazard ratio 0.73 (95% confidence interval 0.52 to 1.03)). A variety of therapeutic approaches including novel antivirals, modifiers of the immune response or other intrinsic pathways, and combination approaches are needed to continue to improve outcomes in patients with Covid-19. DOI: 10.1056/NEJMoa2007764, Tap into groundbreaking research and clinically relevant insights. 3. 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). News Releases. — all in Maryland; Emory University, Atlanta (A.K.M. The amendment was finalized on April 2, 2020, and the initial primary outcome was retained as the key secondary outcome. A total of 68 sites ultimately joined the study—47 in the United States and 21 in countries in Europe and Asia. ); National Center for Infectious Diseases–Tan Tock Seng Hospital–Lee Kong Chian School of Medicine–Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L. At that time, the data and safety monitoring board recommended that the preliminary primary analysis report and mortality data from the closed safety report be provided to trial team members from the National Institute of Allergy and Infectious Diseases (NIAID). Kaplan–Meier Estimates of Cumulative Recoveries. 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. If a hospital had a written policy or guideline for use of other treatments for Covid-19, patients could receive those treatments. |   Get the latest research information from NIH. This benefit was not seen with the 10-day course (P=0.18).15 We believe that these other studies support our findings regarding the efficacy of remdesivir; however, our study was larger, blinded, and fully enrolled. Race and ethnic group were reported by the patients. Cumulatively, these findings suggest that treatment with remdesivir may not only reduce the disease burden but may also decrease the use of scarce health care resources during this pandemic. A trial of lopinavir–ritonavir in adults hospitalized with severe Covid-19. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. 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%). The CONSORT Group. Secondary outcomes included clinical status at day 15 and mortality at day 28. The authorized source of trusted medical research and education for the Chinese-language medical community. A complete list of members of the ACTT-1 Study Group is provided in the Supplementary Appendix, available at NEJM.org. The primary outcome of the current trial was changed early in the trial, from a comparison of the eight-category ordinal scale scores on day 15 to a comparison of time to recovery up to day 29. — all in California; University of Minnesota (S.K.) S7). 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. We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Mortality over the entire study period uses the totality of the study data and censors data from patients who completed follow-up alive at 28 days postenrollment. The RECOVERY Trial also failed to support the use of lopinavir-ritonavir in patients hospitalized with Covid-19, as previously reported by BreakingMED. This double-blind, randomized, placebo-controlled trial identified an antiviral therapy as beneficial in the treatment of Covid-19. Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days. The trial has also been funded in part by the governments of Denmark, Japan, Mexico, and Singapore. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Wang Y, Zhang D, Du G, 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). Among the 285 patients who were receiving mechanical ventilation or ECMO at enrollment, patients in the remdesivir group received these interventions for fewer subsequent days than those in the placebo group (median, 17 days vs. 20 days), and the incidence of new mechanical ventilation or ECMO use among the 766 patients who were not receiving these interventions at enrollment was lower in the remdesivir group than in the placebo group (13% [95% CI, 10 to 17] vs. 23% [95% CI, 19 to 27]) (Table 3). § The ordinal score at day 15 is the patient’s worst score on the ordinal scale during the previous day. The benefit of remdesivir was most apparent in patients with a baseline ordinal score of 5 (receiving low-flow oxygen). Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 10 days, as compared with 15 days; rate ratio for recovery, 1.29; 95% confidence interval [CI], 1.12 to 1.49; P<0.001) (Figure 2 and Table 2). On 15 October, a pre-print paper on the findings of the Solidarity Trial revealed: “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay.” and NYU Langone Health and NYC Health and Hospitals–Bellevue (K.D. 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. There were 60 trial sites and 13 subsites in the United States (45 sites), Denmark (8), the United Kingdom (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1). Sheahan TP, Sims AC, Leist SR, et al. 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. 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