Safety and Efficacy of Drugs Given Off-label for COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Severe adverse events
研究概览
简要总结
We performed a quasi-experimental open-label pragmatic study alternating standard of care (SOC) and oral bedtime melatonin (OBM) at different high doses over 4 consecutive time periods enrolling all consecutive RT-PCR SARS-CoV-2 severe Covid-19 admissions.
详细描述
The 4 successive study time periods spanned from March 2020 to April 2021 and included: 1) standard of care (SOC) (C1), 2) SOC + oral bedtime melatonin (OBM) (T1), 3) SOC (C2), and 4) SOC + OBM (T2). During T1, 3 consecutive subgroups received 50 mg, 100 mg and 200 mg OBM. During T2, 100 mg OBM was given. Melatonin was administered from ICU admission to hospital discharge or death.
The main objectives were occurrence of predefined severe adverse events (SAEs), Sequential Organ Failure Assessment (SOFA) scores and day-30 (D30) and 90 (D90) mortality. Study subjects were followed for modified Rankin scale (mRS) at 30 days after the last OBM dose or hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive RT-PCR for SARS-CoV-2
排除标准
- •Anticipated death within 48 hours or paliative care
研究组 & 干预措施
Oral bedtime melatonin
Standard of care with oral bedtime melatonin
干预措施: Oral bedtime melatonin (Drug)
结局指标
主要结局
Severe adverse events
时间窗: From date of inclusion until date of hospital discharge or death
predefined severe adverse events
Organ dysfunction
时间窗: On days 1, 4, 7, 14 and 30 since first dose of melatonin
Sequential organ failure assessment score
Mortality
时间窗: On days 30 and 90 since first dose of melatonin
From date of inclusión to date of day 30 and day 90 mortality
次要结局
- Length of stay(Date of inclusion until date of ICU and hospital discharge or death)
研究者
Miguel Sanchez Garcia
Director Critical Care
Hospital San Carlos, Madrid