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Remdesivir for the Treatment of Covid-19 — Final Report朗讀者：Dr. Stephen Morrissey, NEJM執行主編應用瑞德西韋治療COVID-19：人們已對治療COVID-19的數種藥物進行了評估，但迄今所有抗病毒藥均被證實無效。體外研究發現瑞德西韋對SARS-CoV-2有抑制作用，因此被確定為可能的候選治療藥物。短視頻中總結了新的研究發現。瑞德西韋治療COVID-19的最終報告
Remdesivir for the Treatment of Covid-19 — Final Report
背景
人們已經對治療2019冠狀病毒病（COVID-19）的多種藥物進行了評估，但迄今為止評估的所有抗病毒藥均被證實無效。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.方法
我們開展了一項雙盲、隨機、安慰劑對照試驗，目的是評估靜脈輸注瑞德西韋對確診下呼吸道感染的COVID-19成人住院患者的療效。患者被隨機分配接受最多10天的瑞德西韋（第1天給予200 mg負荷劑量，之後每天給予100 mg，連續治療最多9天）或安慰劑治療。主要結局是恢復時間，其定義為出院或只是為了控制感染而住院。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. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.結果
共計1062例患者接受了隨機分組（瑞德西韋組541例，安慰劑組521例）。瑞德西韋治療組的中位恢復時間為10天（95%置信區間[CI]，9⁓11），而安慰劑組為15天（95% CI，13~18）（恢復率比，1.29；95% CI，1.12~1.49；時序檢驗P<0.001）。其中一項分析採用比例優勢模型進行分析，模型納入8分等級量表；分析結果顯示，在第15天時，瑞德西韋治療組患者臨床病情改善的可能性高於安慰劑組（針對疾病實際嚴重程度進行校正後，優勢比，1.5；95% CI，1.2⁓1.9）。我們採用Kaplan-Meier曲線估計15天內死亡率，瑞德西韋組為6.7%，安慰劑組為11.9%；29天內的死亡率，瑞德西韋組為11.4%%，安慰劑組為15.2%（風險比，0.73；95% CI，0.52~1.03）。瑞德西韋組532例患者中有131例（24.6%）報告了嚴重不良事件，安慰劑組516例患者中有163例（31.6%）報告了嚴重不良事件。
Result
A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). 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). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). 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%).
結論
本研究的結果證實，在確診下呼吸道感染的COVID-19成人住院患者中，在縮短恢復時間方面，瑞德西韋優於安慰劑。（由美國國立過敏和傳染病研究所（National Institute of Allergy and Infectious Diseases）等資助；ACCT-1在ClinicalTrials.gov註冊號為NCT04280705。）
Conclusions
Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.)
John H. Beigel, Kay M. Tomashek, Lori E. Dodd, et al. Remdesivir for the Treatment of Covid-19 — Final Report. DOI:10.1056/NEJMoa2007764關注《NEJM醫學前沿》
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