AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 157
- 试验地点
- 82
- 主要终点
- Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44
研究概览
简要总结
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19.
Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen.
The study is seeking participants who:
- Have a confirmed COVID-19 infection
- Are Immunocompromised
- Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.
In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir.
For this group, the study is seeking participants who:
- Have a confirmed COVID-19 infection
- Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
- The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir
- Are Immunocompromised
- Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.
All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 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
- 未提供
排除标准
- •Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization
- •Known medical history of active liver disease
- •Known HIV infection with a viral load >400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV)
- •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
- •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 followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 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 followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days
干预措施: Ritonavir (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 followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days
干预措施: Placebo for 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 followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days
干预措施: Placebo for ritonavir (Drug)
Nirmatrelvir plus ritonavir for 10 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days
干预措施: Nirmatrelvir (Drug)
Nirmatrelvir plus ritonavir for 10 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days
干预措施: Ritonavir (Drug)
Nirmatrelvir plus ritonavir for 10 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days
干预措施: Placebo for nirmatrelvir (Drug)
Nirmatrelvir plus ritonavir for 10 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days
干预措施: Placebo for ritonavir (Drug)
Nirmatrelvir plus ritonavir for 15 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.
干预措施: Nirmatrelvir (Drug)
Nirmatrelvir plus ritonavir for 15 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.
干预措施: Ritonavir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44
时间窗: From Day 15 to Day 44
NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \<LLOQ (\<2.0 log10 copies/mL).
次要结局
- Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline(Day 1 through Day 44)
- Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline(Day 1 through Day 44)
- Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24(Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24)
- Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44(Baseline; Days 5, 10, 15, 21, 28, 35 and 44)
- Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44(Baseline; Days 5, 10, 15, 21, 28, 35 and 44)
- Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44(Baseline; Days 5, 10, 15, 21, 28, 35 and 44)
- Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up(Day 16 through Day 44)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation(Day 1 of dosing up to Week 24)
- Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28(Day 1 through Day 28)
- Percentage of Participants With Death Through Week 24(Day 1 through Week 24)
- Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24(Day 1 through Day 44 and Day 1 through Week 24)
- Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24(Day 1 through Day 44 and Day 1 through Week 24)
- Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24(Day 1 through Day 44 and Day 1 through Week 24)
- Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24(Day 1 through Day 44 and Day 1 through Week 24)
- Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24(Day 1 through Day 44 and Day 1 through Week 24)
- Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44(Day 1 through Day 44)
- Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44(Day 1 through Day 44)
- Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44(Day 1 through Day 44)