CTRI/2020/06/026192已完成2 期
A randomised, double-blind, placebo-controlled, phase 2 trial investigating the safety and efficacy of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation - The ATTRACT Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure.
- •2) Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test less than 4 days before Visit 1 with signs of an acute respiratory infection.
- •3) Age more than equal to 18 and less than equal to 70 years.
- •4) CRP more than 50 and less than 150 mg/l.
- •5) Admitted to a hospital or controlled facility (home quarantine is not sufficient)
- •6) In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol.
排除标准
- •1) Any previous experimental treatment for COVID-19
- •2) Need for mechanical invasive or non-invasive ventilation
- •3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis
- •4) Participation in any other interventional trial within 3 months prior to Visit 1
- •5) Any of the following findings at Visit 1:
- •a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab)
- •b Positive pregnancy test (see Section 8.2.3).
- •6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
- •7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial
- •8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
- •9) Treatment with any of the medications listed below within 1 week prior to Visit 1:
- •a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates)
- •b. Warfarin
- •10) Pregnant or breast-feeding female subjects
- •11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1
- •12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1
- •13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
研究者
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