A Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Virological Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sirolimus Adjuvant Therapy in Patients With Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment
研究概览
简要总结
This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female >/=18 and </=65 years of age at the time of consent
- •Laboratory confirmed SARS-CoV-2 infection
- •Investigator-estimated hospitalization duration of at least 5 days
排除标准
- •Need for >4 liters nasal cannula oxygen to maintain oxygen saturation >90%
- •Hypersensitivity to sirolimus
- •Pregnant or breastfeeding
- •Anticipated transfer to another study hospital within 72 hours
- •Alanine transaminase (ALT) >3 times the upper limit of normal
- •Creatinine clearance <30mL/min as estimated by Cockcroft-Gault
- •Underlying immunosuppression due to daily >5 mg prednisone equivalent a day, prior solid organ transplant, or other immunosuppression deemed by investigator to be potentially unsafe
- •Co-administration with strong inhibitors of CYP3A4 and/or P-glycoprotein (P-gp) (such as ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin and others)
- •Co-administration with strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) (such as phenytoin or rifampin)
- •Anticipated surgery within 1 month
- •Need for healing of a fracture or a significant soft tissue wound
研究组 & 干预措施
Sirolimus
Sirolimus + standard medical care Day 1: 10mg Days 2-7: 5mg
干预措施: Sirolimus 1 MG/ML (Drug)
Placebo
Placebo + standard medical care Day 1: 10mL Days 2-7: 5mL
干预措施: Placebo (Drug)
结局指标
主要结局
Change in SARS-CoV-2 viral burden from baseline to day 7 of treatment
时间窗: Baseline, and days 1, 2, 3, 4, 5, 6, & 7 post-dose for all patients
SARS-CoV-2 viral burden will be quantified for both arms using a qRT-PCR
次要结局
- Rate of treatment emergent adverse events(Days 1, 2, 3, 4, 5, and 6 post-dose for all patients)
- Change in SARS-CoV-2 viral burden at days 1-6(Days 1, 2, 3, 4, 5, and 6 post-dose for all patients)
研究者
Walter K. Kraft
Principal Investigator
Thomas Jefferson University