Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia (The SCOPE Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
研究概览
简要总结
The main objective of our study is to determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19. The investigators will employ a randomized, double blind, placebo-controlled study design. 28 subjects were randomized in a 2:1 fashion to receive sirolimus or placebo. Sirolimus will be given as a 6mg oral loading dose on day 1 followed by 2mg daily for a maximum treatment duration of 14 days or until hospital discharge, whichever happens sooner. Chart reviews will be conducted daily to determine changes in clinical status, concomitant medications and laboratory parameters. Study specific biomarkers will be measured at baseline and then at days 3, 7 and 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects enrolled in the trial must meet all of the following criteria.
- •Confirmed COVID-19 pneumonia
- •Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
- •Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count <1,000/uL
- •Age ≥ 18 years
- •Completed informed consent
排除标准
- •Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:
- •Known allergy or hypersensitivity to sirolimus
- •Inability or refusal to provide informed consent
- •Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
- •Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
- •Pregnant women
- •Breast feeding
- •On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4
- •Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):
- •History of liver cirrhosis
- •End stage renal disease or need for renal replacement therapy
- •Decompensated heart failure
- •Known active tuberculosis or history of incompletely treated tuberculosis
- •Uncontrolled systemic bacterial or fungal infections
- •Active viral infection other than COVID-19
研究组 & 干预措施
Sirolimus
Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.
干预措施: Sirolimus (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients Who Are Alive and Free From Advanced Respiratory Support Measures at Day 28.
时间窗: 28 days
Death or progression to respiratory failure requiring advanced support measures, either due to inadequate ventilation (non-invasive or invasive mechanical ventilation) or inadequate oxygenation (CPAP\* or high flow supplemental oxygen at rates ≥ 15 liters/minute), in patients given sirolimus compared to the placebo group. \* CPAP use for known obstructive sleep apnea will not be considered as disease progression.
次要结局
- Percentage of Patients Surviving to Hospital Discharge(28 days)
- Drug Safety Profile(28 days)
- Duration of Hospital Stay(days)
- Number of Patients Who Require Initiation of Off-label Therapies(28 days)
研究者
Nishant Gupta, MD, MS
Adjunct Associate Professor
University of Cincinnati