NCT04960202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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,091
- 试验地点
- 199
- 主要终点
- Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
研究概览
简要总结
The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or 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)
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 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
研究组 & 干预措施
PF-07321332/ritonavir
Experimental
Orally administered PF-07321332+ritonavir
干预措施: Ritonavir (Drug)
Placebo
Placebo Comparator
Orally administered placebo
干预措施: Placebo (Drug)
PF-07321332/ritonavir
Experimental
Orally administered PF-07321332+ritonavir
干预措施: PF-07321332 (Drug)
结局指标
主要结局
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
时间窗: From Day 1 to Day 28
Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.
次要结局
- Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population(From Day 1 (baseline) to Day 28)
- Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)(From start of study intervention (Day 1) up to end of safety follow-up (Day 34))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From start of study intervention (Day 1) up to end of safety follow-up (Day 34))
- Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population(From Day 1 to Day 28)
- Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population(From Day 1 to Day 28)
- Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population(From Day 1 to Day 28)
- Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population(From Day 1 (baseline) to Day 28)
- Plasma Concentration Versus Time Summary of PF-07321332(1 Hour post-dose on Day 1 and pre-dose on Day 5)
- Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population(From Day 1 to Day 28)
- Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population(From Day 1 (baseline) to Day 28)
- Percentage of Participants Who Died Through Week 24- mITT Population(From Day 1 up to Week 24)
- Percentage of Participants Who Died Through Week 24- mITT2 Population(From Day 1 up to Week 24)
- Number of COVID-19 Related Medical Visits- mITT1 Population(From Day 1 up to Day 34)
- Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population(From Day 1 (baseline) to Day 28)
- Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population(From Day 1 (baseline) to Day 28)
- Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population(From Day 1 (baseline) to Day 28)
- Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population(Day 1, 5)
- Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population(Day 1, 5)
- Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population(Baseline, Day 3, 5, 10 and 14)
- Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population(From Day 1 up to Day 34)
- Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population(From Day 1 (baseline) to Day 28)
- Percentage of Participants Who Died Through Week 24- mITT1 Population(From Day 1 up to Week 24)
- Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population(Baseline, Day 3, 5, 10 and 14)
- Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population(From Day 1 up to Day 34)
- Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population(From Day 1 (baseline) to Day 28)
- Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population(From Day 1 (baseline) to Day 28)
- Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population(From Day 1 (baseline) to Day 28)
- Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population(Day 1, 5)
- Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population(Baseline, Day 3, 5, 10 and 14)
- Number of COVID-19 Related Medical Visits- mITT Population(From Day 1 up to Day 34)
- Number of COVID-19 Related Medical Visits- mITT2 Population(From Day 1 up to Day 34)
- Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population(From Day 1 up to Day 34)
研究者
研究点 (199)
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