COVID-19：Reddy博士在科威特完成AVIGAN试验：早期感染的治疗作用
印度仿制药巨头Doctor Lady’s Laboratories
AVIGAN临床试验：
1月28日之前，“科威特COVID-19候选AVIGAN的COVID-19候选者临床试验”将完成。
科威特的临床试验结果：
FUJIFILM Holdings提供Avigan。
353名中病患者参加。
与接受安慰剂的患者相比，接受Avigan的患者
直到症状改善的天数缩短了一天。
但是，确认有效性没有显着差异。
另一方面，在感染的早期阶段，对具有轻度症状的患者观察到治疗效果。
日本经济新闻
https://www.nikkei.com/article/DGXZQODZ283WA0Y1A120C2000000
Dr. Reddy’s and GRA announce Avigan Pivotal Studies Update Study for hospitalized moderate to severe cases in Kuwait terminated,
while study for out-patient mild to moderate cases continues in North America
Hyderabad, India, January 27, 2021:
Dr. Reddy’s Laboratories Ltd. and
Global Response Aid FZCO (GRA)
today announced the termination of the Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID-19 patients in a hospital setting.
The hospitalized patient study, conducted in Kuwait, on moderate to severe patients
was one of the studies in the overall clinical program for Avigan, spanning the spectrum of asymptomatic to severe cases of COVID-19 in both out-patient and in-patient setting.
The Phase-III study, being conducted in an out- patient setting on patients with mild to moderate symptoms in North America by Dr. Reddy’s, in partnership with Appili Therapeutics and Global Response Aid, shall continue.
The data from the Kuwait CVD-04-CD-001 study involving moderate to severe COVID-19 hospitalized patients
did not show a statistically significant difference for the primary endpoint (i.e., time to sustained hypoxia resolution) for Avigan vs. placebo (7 days vs. 8 days; p= >0.05).
The full data analysis on 353 subjects would be available by the end of February 2021.
Within this group, there was subgroup analysis carried out on 181 patients in the low risk category.
The subgroup analysis of the low-risk (low NEWS Score at admission) study cohort (n=181) demonstrated a 3 day earlier discharge in the Avigan group compared to the placebo group (8 days vs. 11 days; p=0.0063) for time to hospital discharge secondary endpoint.
The subgroup analysis data during the initial interim analysis points towards the hypothesis with clinically significant insights from this study
that an antiviral drug such as Avigan may be effective as part of early treatment initiation in COVID-19 patients and not effective in the late-stage hospital treatment for moderate and severe COVID-19 patients.
Dr. Reddy’s, in partnership with Appili Therapeutics and Global Response Aid,
shall continue the Phase III pivotal study [PRESECO] being conducted in North America in an out-patient setting.
The PRESECO study
aims to determine the efficacy of Avigan as an early treatment for COVID-19 patients with mildto moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions.
Additional observational studies to evaluate the efficacy of Avigan as part of early treatment in COVID-19 patients are also initiated.
Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.
https://www.drreddys.com/media/928938/2021-01-avigan-trial-update_v1.pdf