JPRN-jRCT2031210274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 LOW RISK OF PROGRESSING TO SEVERE ILLNESS
Kawai Norisuke0 个研究点目标入组 1,288 人开始时间: 2021年8月26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
- 1,288
研究概览
简要总结
irmatrelvir/ritonavir reduced the time to sustained alleviation of all targeted signs and symptoms through Day 28, but the difference was not statistically significant and the study primary objective was not met; the secondary analysis results were not statistically significant despite some positive results. The antiviral effect of nirmatrelvir/ritonavir was demonstrated by a significant reduction of SARS-CoV-2 viral load compared with placebo at Day 5. 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 5 days prior to randomization
- •* Initial onset of COVID-19 signs/symptoms within 5 days of randomization
- •* Fertile participants must agree to use a highly effective method of contraception
排除标准
- •*Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
- •*History of or need for hospitalization for the medical treatment of COVID-19.
- •*Prior diagnosis of SARS-CoV-2 infection (reinfection)
- •*Known medical history of liver disease
- •*Receiving dialysis or have known renal impairment
- •*Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
- •*Suspected or confirmed concurrent active systemic infection other than COVID-19
- •*Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
- •*Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
- •*Has received any SARS-CoV-2 vaccine within 12 months of screening.
- •*Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
- •*Known prior participation in this trial or other trial involving PF-07321332
- •*Oxygen saturation of < 92% on room air
- •*Females who are pregnant or breastfeeding
研究者
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