Remdesivir for the Treatment of Covid-19 Final Report
Table of Content
Adverse events, including severe allergic reactions, after COVID-19 vaccination are rare but can happen. For this reason, everyone who receives a COVID-19 vaccine is monitored by their vaccination provider for at least 15 minutes. The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021.
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A total of 54 of the patients who were in the mild-to-moderate stratum at randomization were subsequently determined to meet the criteria for severe disease, resulting in 105 patients in the mild-to-moderate disease stratum and 957 in the severe stratum. The as-treated population included 1048 patients who received the assigned treatment . 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. Here, we describe the first stage of the Adaptive Covid-19 Treatment Trial (ACTT-1), in which we evaluated treatment with remdesivir as compared with placebo. The results presented here represent an update to a preliminary report after complete follow-up.
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Information on interactions of treatment with baseline ordinal score with respect to mortality is provided in Table S11. 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) . The trial protocol was approved by the institutional review board at each site and was overseen by an independent data and safety monitoring board. 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.
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Go back and select "Option A" to start your account setup with AllianceRx Walgreens Prime. †Recovery rate ratios and hazard ratios were calculated from the stratified Cox model; the P value for this ratio was calculated with the stratified log-rank test . Recovery rate ratios greater than 1 indicate a benefit with remdesivir; hazard ratios less than 1 indicate a benefit with remdesivir. A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. V-safe, a smartphone-based tool, provides quick and confidential health check-ins via text messages and web surveys. It does this so you can quickly and easily share with CDC how you or your child feel after getting a COVID-19 vaccine.
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.
The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. 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. Sensitivity analyses evaluating the unblinding and crossover produced results similar to those of the primary analysis . The primary outcome was initially a comparison of clinical status at day 15 on the eight-category ordinal scale. 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 benefit of remdesivir was most apparent in patients with a baseline ordinal score of 5 (receiving low-flow oxygen).
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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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