EUCTR2020-001052-18-GB进行中（未招募）1 期
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults - Adaptive COVID-19 Treatment Trial (ACTT)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.
- •2.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •3.Understands and agrees to comply with planned study procedures.
- •4.Male or non-pregnant female adult =18 years of age at time of enrolment.
- •5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.
- •Note – 72 hours is not necessarily time from initial diagnosis. If =72 hours since positive PCR, the PCR may be repeated to assess eligibility.
- •6.Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation.
- •7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
- •8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. ALT/AST > 5 times the upper limit of normal.
- •2.Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis.
- •3.Pregnancy or breast feeding.
- •4.Anticipated transfer to another hospital which is not a study site within 72 hours.
- •5.Allergy to any study medication.
研究者
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