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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).
研究概览
简要总结
A randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of C21 200 mg daily dose (100 mg b.i.d) on top of standard of care for 7 days. Approximately 100 subjects with COVID-19 infection will be randomised 1:1 to receive either standard of care and C21 (50 participants) or standard of care and placebo (50 participants). All subjects will be followed-up 7-10 days after receiving the last investigational medicinal product (IMP) dose (visit or phone call, if recovering at home). The primary objective is to investigate the efficacy of C21 200 mg daily dose (100 mg b.i.d.) on COVID-19 infection not requiring mechanical invasive or non-invasive ventilation.
Rationale for trial:
There is no cure or effective specific therapeutics for treating patients with COVID-19. A 51% mortality has been reported in the UK for patients in critical care (ICNARC 2020). The standard of care is primarily focussed on organ support such as respiratory failure. A safe and effective treatment is urgently needed to reduce mortality and improve clinical disease outcome such as from ARDS which is thought to manifest from the exuberant cytokine storm associated with the adaptive stage of the disease. The current clinical trial is the first investigation of C21 in patients infected with COVID-19. Data from the trial will guide and support the design of further clinical investigations of C21 in this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure.
- •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.
- •Age more than equal to 18 and less than equal to 70 years.
- •CRP more than 50 and less than 150 mg/l.
- •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
- •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).
- •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. John’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).
结局指标
主要结局
Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).
时间窗: The primary endpoint will be the change in CRP from baseline to the average of the last 2 assessments during the treatment period.
次要结局
- 1) Change from baseline in:(a. Body temperature)
- Exploratory Endpoint:(Blood samples will be stored for potential future analyses of biomarkers reflecting inflammation and lung injury.)