POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFECTIVENESS OF PAXLOVID IN PATIENTS, AND WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Proportion of patients with a serious AE (SAE)
研究概览
简要总结
The purpose of this study is to look at the safety and effectiveness of PAXLOVID in the real world and not in clinical studies. The study observes patients who have a high chance of getting severe COVID-19 in Korea.
This study is seeking participants who are:
- Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death.
- Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
- Patients who have signed informed consent documents after understanding all the important parts of the study.
All participants are treated according to routine medical practice and there are no scheduled visits required by this study. All participants will be studied for a follow-up period of 28 days from the last PAXLOVID treatment to understand the safety and the effectiveness of treatment.
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 其他
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
- Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.
排除标准
- Patients with contraindication according to locally approved label of PAXLOVID.
- Patients who are going to receive any investigational medicine during the observation period.
研究组 & 干预措施
Participants receiving PAXLOVID
Participants receiving PAXLOVID according to locally approved label.
结局指标
主要结局
Proportion of patients with a serious AE (SAE)
时间窗: Baseline through Day 33
The number of SAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with an adverse drug reaction (ADR)
时间窗: Baseline through Day 33
The number of ADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with a serious unexpected AE (SUAE)
时间窗: Baseline through Day 33
The number of SUAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of COVID-19-related death from any cause
时间窗: Baseline through Day 33
The number and rate of COVID-19-related deaths among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with an unexpected ADR (UADR)
时间窗: Baseline through Day 33
The number of UADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with a serious ADR (SADR)
时间窗: Baseline through Day 33
The number of SADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of COVID-19-related hospitalization from any cause
时间窗: Baseline through Day 33
The number and rate of COVID-19-related hospitalizations among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with an adverse event (AE)
时间窗: Baseline through Day 33
The number of AEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with a serious unexpected ADR (SUADR)
时间窗: Baseline through Day 33
The number of SUADRs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of subjective assessment of COVID-19-related symptomatic change
时间窗: Day 5, Day 14, Day 33
The rate of subjective assessment change (improve/no change/worsened) compared to the baseline for COVID-19-related overall symptoms of all subjects who received the drug and received at least one safety evaluation will be measured.
Proportion of patients with an unexpected AE (UAE)
时间窗: Baseline through Day 33
The number of UAEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05890612
- 其他研究编号
- C4671020, NCT05890612
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.