AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 436
- 试验地点
- 81
- 主要终点
- Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound.
The study is seeking participants who:
- Have completed treatment with nirmatrelvir/ritonavir
- Have a rebound in COVID-19 symptoms
- Are SARS-CoV-2 (COVID-19) positive
All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home.
We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective.
People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. Symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
- •Onset of rebound in COVID-19 symptoms within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
- •Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and ≥1 sign/symptom attributable to COVID-19 present on the day of randomization.
- •SARS-CoV-2 infection as determined by rapid antigen testing within 24 hours prior to randomization
- •At least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
排除标准
- •Current need for hospitalization, hospitalized for the COVID-19 infection or anticipated need for hospitalization within 24 hours after randomization
- •History of severe chronic liver disease
- •Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) <30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device
- •Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization
- •Immunocompromised.
- •Current use of any prohibited concomitant medication(s)
- •Females who are pregnant and <14 weeks gestation
研究组 & 干预措施
nirmatrelvir plus ritonavir for 5 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
干预措施: nirmatrelvir (Drug)
nirmatrelvir plus ritonavir for 5 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
干预措施: ritonavir (Drug)
placebo plus ritonavir for 5 days
placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
干预措施: ritonavir (Drug)
placebo plus ritonavir for 5 days
placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
干预措施: placebo for nirmatrelvir (Drug)
结局指标
主要结局
Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population
时间窗: Baseline, Day 5
Baseline was defined as the latest measurement between Day -1 and Day 1, but post-dose samples that were collected within 1 hour post start of dosing were also treated as baseline. Samples with result "\< lower limit of quantification (LLOQ)" were imputed as 1.7 log10 copies/milliliter (mL), and samples with result "Not Detected" were imputed as 0.0 log10 copies/mL.
次要结局
- Time to Two Consecutive Negative Rapid Antigen Test (RAT) Results At Least 24 Hours Apart Through Day 28: mITT Population(Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first)
- Time to Sustained Alleviation of All Targeted Signs and Symptoms Through Day 28: mITT Population(Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation From Study(Day 1 of dosing up to maximum Week 24 follow-up)