临床试验/NCT04364022

NCT04364022已完成3 期

Efficacy of Pragmatic Same-day Ring COVID-19 Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland: an Open-label Cluster Randomized Trial

Calmy Alexandra4 个研究点分布在 2 个国家目标入组 326 人开始时间: 2020年4月23日最近更新: 2021年4月12日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 326
试验地点: 4
主要终点: 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A study to assess, in a two-arm open-label cluster randomized clinical trial, the efficacy of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Lopinavir/Ritonavir

Active Comparator

干预措施: Lopinavir/ritonavir (Drug)

结局指标

主要结局

21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).

时间窗: 21-day

次要结局

21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)(21-day)
Severity of clinical COVID-19 on a 7-point ordinal scale(21-day)
21-day incidence of SARS-CoV-2 infection in individuals exposed to SARS-CoV-2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)(21-day)

研究者

发起方

Calmy Alexandra

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Calmy Alexandra

Prof. Alexandra Calmy

University Hospital, Geneva

研究点 (4)

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