General Investigation for PAXLOVID PAC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,346
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Drug Reactions
研究概览
简要总结
The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:
- Have taken PAXLOVID PACK and have no history of using this medicine.
- Are 12 years and older
All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.
We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.
Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.
详细描述
This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects who are administered PAXLOVID PACK and have no history of using this drug.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
PAXLOVID PACK
Subjects administered PAXLOVID PACK
干预措施: nirmatrelvir / ritonavir (Drug)
结局指标
主要结局
Incidence of Adverse Drug Reactions
时间窗: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.
Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician.
次要结局
- Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)(From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.)
- Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)(From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.)
- Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)(From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.)
- Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)(3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.)
- Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)(3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.)