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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1,440
- 试验地点
- 220
- 主要终点
- Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28
研究概览
简要总结
The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.
详细描述
Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
PF-07321332/ritonavir
Orally administered PF-07321332+ritonavir
干预措施: PF-07321332 (Drug)
PF-07321332/ritonavir
Orally administered PF-07321332+ritonavir
干预措施: Ritonavir (Drug)
Placebo
Orally administered Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28
时间窗: From Day 1 to Day 28
Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation(From start of study intervention (Day 1) up to Day 34)
- Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28(From Day 1 to Day 28)
- Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms(From Day 1 to Day 28)
- Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28(From Day 1 to Day 28)
- Percentage of Participants With Death Through Week 24(From Day 1 to Week 24)
- Plasma Concentration Versus Time Summary of PF-07321332(Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose)
- Number of COVID-19 Related Medical Visits Per Day Through Day 28(From Day 1 to Day 28)
- Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28(From Day 1 to Day 28)
- Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28(From Day 1 to Day 28)
- Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28(From Day 1 to Day 28)
- Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5(Day 1 and Day 5)
- Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28(From Day 1 to Day 28)
- Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14(Baseline, Days 3, 5, 10 and 14)