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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). 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 primary analysis was a stratified log-rank test of time to recovery with remdesivir as compared with placebo, with stratification by disease severity . (See the Supplementary Appendix for more information about the planned statistical analysis.) 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. Given the preliminary results about remdesivir, the Food and Drug Administration issued an Emergency Use Authorization on May 1, 2020 , to permit the use of remdesivir for treatment in adults and children hospitalized with suspected or laboratory-confirmed Covid-19. Remdesivir has also received full or conditional approval in several other countries since that time.
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Full details of the trial design, conduct, oversight, and analyses can be found in the protocol and statistical analysis plan (available with the full text of this article at NEJM.org). NantHealth supports payers with technology to manage rising costs and regulatory requirements. Decision support and treatment plan validation solutions for oncology and autoimmune diseases ensure members receive timely, evidence-based care at the best cost. Scalable payer-provider collaboration solutions enable seamless communications and information sharing for maximum efficiency and savings. ‡Mortality over the first 14 days includes data from all patients who were still alive through 14 days postenrollment, with data censored on day 15, as if 14 days was the maximum follow-up time.
Eleven patients (1.0%) had missing ordinal scale data at enrollment; all these patients discontinued the study before treatment. During the study, 373 patients (35.6% of the 1048 patients in the as-treated population) received hydroxychloroquine and 241 (23.0%) received a glucocorticoid . 2) was 94% or lower while they were breathing ambient air, or if they had tachypnea (respiratory rate ≥24 breaths per minute). Remdesivir was administered intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily on days 2 through 10 or until hospital discharge or death. A matching placebo was administered according to the same schedule and in the same volume as the active drug. 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.
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You can find your plan's drug list on your pharmacy member ID card or bysigning in. ‡Data on symptom onset were missing for 3 patients; data on coexisting conditions were missing for 11 patients and were incomplete for 3 patients. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Fact sheet for healthcare workers to give after vaccination. Adverse events are rare but can cause long-term health problems.
Possible Side Effects After Getting a COVID-19 Vaccine
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Little was known about the natural clinical course of Covid-19 when the trial was designed in February 2020. Emerging data suggested that Covid-19 had a more protracted course than was previously known, which aroused concern that a difference in outcome after day 15 would have been missed by a single assessment at day 15. The amendment was proposed on March 22, 2020, by trial statisticians who were unaware of treatment assignment and had no knowledge of outcome data; when this change was proposed 72 patients had been enrolled. 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. In the end, findings for both primary and key secondary end points were significantly different between the remdesivir and placebo groups. On April 27, 2020, the data and safety monitoring board reviewed efficacy results.
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Information reflecting prices is not a quotation or offer to sell or purchase. The clinical information contained in the information is intended as a supplement to, and not a substitute for, the knowledge, expertise, skill, and judgment of physicians, pharmacists, or other healthcare professionals in patient care. The absence of a warning for a given drug or drug combination should not be construed to indicate that the drug or drug combination is safe, appropriate or effective in any given patient. Patients in the remdesivir group had a shorter time to discharge or to a National Early Warning Score of 2 or lower than those in the placebo group (median, 8 days vs. 12 days; hazard ratio, 1.27; 95% CI, 1.10 to 1.46). 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.
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Sign in to get prices and information specific to your benefits. †Race and ethnic group were reported by the patients. The number of patients in other races and ethnic groups are listed in Table S1 in the Supplementary Appendix. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
The key secondary outcome was clinical status at day 15, as assessed on the ordinal scale. Secondary safety outcome measures included grade 3 and 4 adverse events and serious adverse events that occurred during the trial, discontinuation or temporary suspension of infusions, and changes in assessed laboratory values over time. 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.
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