Hobbs F D Richard, Montgomery Hugh, Padilla Francisco, Simón-Campos Jesus Abraham, Kim Kenneth, Arbetter Douglas, Padilla Kelly W, Reddy Venkatesh Pilla, Seegobin Seth, Streicher Katie, Templeton Alison, Viani Rolando M, Johnsson Eva, Koh Gavin C K W, Esser Mark T
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Department of Medicine, University College London, London, UK.
Infect Dis Ther. 2023 Sep;12(9):2269-2287. doi: 10.1007/s40121-023-00861-7. Epub 2023 Sep 26.
INTRODUCTION: We assessed effects of AZD7442 (tixagevimab/cilgavimab) on deaths from any cause or hospitalizations due to coronavirus disease 2019 (COVID-19) and symptom severity and longer-term safety in the TACKLE adult outpatient treatment study. METHODS: Participants received 600 mg AZD7442 (n = 452) or placebo (n = 451) ≤ 7 days of COVID-19 symptom onset. RESULTS: Death from any cause or hospitalization for COVID-19 complications or sequelae through day 169 (key secondary endpoint) occurred in 20/399 (5.0%) participants receiving AZD7442 versus 40/407 (9.8%) receiving placebo [relative risk reduction (RRR) 49.1%; 95% confidence interval (CI) 14.5, 69.7; p = 0.009] or 50.7% (95% CI 17.5, 70.5; p = 0.006) after excluding participants unblinded before day 169 for consideration of vaccination). AZD7442 reduced progression of COVID-19 symptoms versus placebo through to day 29 (RRR 12.5%; 95% CI 0.5, 23.0) and improved most symptoms within 1-2 weeks. Over median safety follow-up of 170 days, adverse events occurred in 174 (38.5%) and 196 (43.5%) participants receiving AZD7442 or placebo, respectively. Cardiac serious adverse events occurred in two (0.4%) and three (0.7%) participants receiving AZD7442 or placebo, respectively. CONCLUSIONS: AZD7442 was well tolerated and reduced hospitalization and mortality through 6 months, and symptom burden through 29 days, in outpatients with mild-to-moderate COVID-19. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT04723394. ( https://beta. CLINICALTRIALS: gov/study/NCT04723394 ).
简介：在TACKLE成人门诊治疗研究中，我们评估了AZD7442（替沙格韦单抗/西加韦单抗）对2019冠状病毒病（COVID-19）所致任何原因死亡或住院、症状严重程度及长期安全性的影响。 方法：参与者在出现COVID-19症状≤7天内接受600mg AZD7442（n = 452）或安慰剂（n = 451）。 结果：在接受AZD7442的20/399名（5.0%）参与者与接受安慰剂的40/407名（9.8%）参与者中，至第169天（关键次要终点）因任何原因死亡或因COVID-19并发症或后遗症住院的情况发生 [相对风险降低（RRR）49.1%；95%置信区间（CI）14.5，69.7；p = 0.009]，或在排除第169天前因考虑接种疫苗而未设盲的参与者后为50.7%（95%CI 17.5，70.5；p = 0.006）。与安慰剂相比，AZD7442可减轻COVID-19症状进展至第29天（RRR 12.5%；95%CI 0.5，23.0），并在1 - 2周内改善大多数症状。在170天的中位安全性随访期内，接受AZD7442或安慰剂的参与者中分别有174名（38.5%）和196名（43.5%）发生不良事件。接受AZD7442或安慰剂的参与者中分别有2名（0.4%）和3名（0.7%）发生心脏严重不良事件。 结论：对于轻至中度COVID-19门诊患者，AZD7442耐受性良好，可降低6个月内的住院率和死亡率，并减轻29天内的症状负担。 临床试验注册：Clinicaltrials.gov，NCT04723394。（https://beta. CLINICALTRIALS: gov/study/NCT04723394 ）
N Engl J Med. 2022-6-9
Lancet Respir Med. 2023-1
Lancet Respir Med. 2023-1
N Engl J Med. 2023-1-5
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