NCT05366244Unknown不适用
An Observational, Real World Study to Observe Disease Outcomes in Patients With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Shanghai Pudong Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to sustained clinical recovery
研究概览
简要总结
The purpose of this study was to observe real-world disease progression in mild-moderate COVID-19 patients with at least one risk factor for serve COVID-19 illness or death.
详细描述
Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
The following is the general sequence of events during the 28-day evaluation period:
Completion of baseline procedures Participants were assessed for 28 days and completed all safety monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have a positive SARS-CoV-2 test result.
- •Participants who have one or more mild or moderate COVID-19 symptoms.
- •Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to Day 1; ≤5 days from the first onset of COVID-19 symptoms to Day
- •Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death.
- •Participants who understand and agree to comply with planned study procedures.
- •Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
- •Capable of giving signed informed consent, including of compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization.
- •Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute.
- •Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
- •Participants who have received or plan to receive a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment).
- •Participants who have received convalescent COVID-19 plasma treatment.
结局指标
主要结局
Time to sustained clinical recovery
时间窗: Up to 28 days
Time to sustained clinical recovery
次要结局
- Percentage of participants with no clinical symptoms(Day 3, 5, 7, 10, 14, 21 and 28)
- Percentage of the participants who have progression of COVID-19(Day 1 to 28 days)
- Percentage of clinical recovery participants(Day 3, 5, 7, 10, 14, 21 and 28)
- The change of SARS-COV-2 Ct value(Day 3, 5, 7, 10, 14)
- The change of COVID-19 symptom scores(Day 3, 5, 7, 10, 14, 21 and 28)
- Percentage of participants who experience these events(Day 1 to 28 days)
- Time to sustained disappearance of clinical symptoms(Up to 28 days)
- Percentage of participants who turned negative for SARS-CoV-2(Day 3, 5, 7, 10, 14)
- Safety assessment Results: such as AEs and SAEs through Day 28(Up to 28 days)
研究者
研究点 (2)
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