JPRN-jRCT2031210267已完成2 期
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Kawai Norisuke0 个研究点目标入组 2,246 人开始时间: 2021年8月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,246
研究概览
简要总结
Treatment with nirmatrelvir/ritonavir was efficacious in reducing the incidence of COVID-19-related hospitalization or death from any cause in nonhospitalized symptomatic adult participants with COVID-19 who were at increased risk of progression to severe disease. Treatment with nirmatrelvir/ritonavir was safe and well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*Confirmed SARS-CoV-2 infection within 5 days prior to randomization
- •*Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
- •*Fertile participants must agree to use a highly effective method of contraception
- •*Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
排除标准
- •*History of or need for hospitalization for the medical treatment of COVID-19
- •*Prior to current disease episode, any confirmed SARS-CoV-2 infection
- •*Known medical history of active liver disease
- •*Receiving dialysis or have known moderate to severe renal impairment
- •*Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
- •*Suspected or confirmed concurrent active systemic infection other than COVID-19
- •*History of hypersensitivity or other contraindication to any of the components of the study intervention
- •*Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
- •*Has received or is expected to receive convalescent COVID-19 plasma
- •*Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
- •*Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
- •*Known prior participation in this trial or other trial involving PF-07321332
- •*Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
- •*Females who are pregnant or breastfeeding
研究者
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