CTRI/2021/09/036116进行中（未招募）2/3 期
A randomized, double-blind, placebo-controlled, parallel group, phase 2/3, multicenter trial investigating the efficacy and safety of C21 as add on to standard of care in adult subjects with COVID-19.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.
研究概览
简要总结
A randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of C21 200 mg daily dose (100 mg b.i.d) as add on to standard of care in adult subjects with COVID-19 for 14 days. Approximately 600 subjects with COVID-19 infection will be randomized 1:1 to receive either standard of care and C21 or standard of care and placebo. All subjects will be followed-up on day 22, 29 & 60. 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:
The corona virus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Although several therapeutic agents have been evaluated for the treatment of COVID-19, the morbidity and mortality are still significant. The need for safe, effective, and convenient COVID-19 drugs is likely to remain even after the launch of vaccine programs. The safety and efficacy of C21 in subjects with COVID-19 have been investigated in a phase 2 trial. The results show that C21, as add on to standard of care (SoC), reduced the need for extended oxygen supplementation and had a favorable benefit/risk profile. The rationale for conducting this phase 2/3 trial is to confirm the efficacy of C21 in subjects with COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent.
- •(Specific for India; Age ≥18 at the time of signing the informed consent to ≤65 years.)
- •Hospitalized due to SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test, documented by either of the following: a.
- •PCR positive in sample collected <72 hours prior to randomization (Visit 2); OR b.
- •PCR positive in sample collected ≥72 hours and ≤7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •A score of 5 or 6 on the 8-point ordinal scale: a.
- •Score 5: Hospitalized, requiring supplemental oxygen.
- •Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device.
- •Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Written informed consent, consistent with International Council for Harmonization (ICH Good Clinical Practice (GCP) R2 and local laws, obtained before the initiation of any trial-related procedure.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Specific for India: For subjects with an ordinal scale score of 5, moderate to severe COVID-19 disease confirmed by at an SpO2 ≤ 93 % or a respiratory rate ≥ 24/min on room air.
- •Note: If a subject is on supplemental oxygen with SpO2 >93% and respiratory rate <24/min, but desaturation to ≤ 93 % or increase of respiratory rate to ≥ 24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion is considered to be met.
排除标准
- •Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
- •Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count <500 cells/mm³).
- •Impaired hepatic function (i.e., Child-Pugh class B or C).
- •Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2).
- •COVID-19 symptom onset >14 days prior to screening (Visit 1).
- •Hospitalized due to COVID-19 for >72 hours at screening (Visit 1).
- •Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1)
- •Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator.
- •Moderate to severe ARDS (e.g., same-day PaO2/FiO2 ≤200 mmHg; or SpO2/FiO2 ≤232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen.
- •Pregnant or breast-feeding female subjects.
- •Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC.
- •Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial: a.
- •Strong Cytochrome P450 (CYP) 3A4 inducers.
- •P-glycoprotein (P-gp) substrates with narrow therapeutic index.
- •High dose BCRP sensitive substrates.
- •Sulphasalazine or rosuvastatin.
- •Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever is longest, prior to screening (Visit 1).
- •Positive pregnancy test
- •Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator.
结局指标
主要结局
Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.
时间窗: Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.
次要结局
- Supplemental oxygen free days up to Day 29.(Will be assessed upto days 29)
- Proportion of subjects free of respiratory failure, defined as an 8-point ordinal scale score more than 6, at Day 15.(Will be assessed on days 15)
- Time to sustained hospital discharge up to Day 60(Will be assessed upto days 60)
- All-cause mortality up to Day 60(Will be assessed upto days 60)
- Adverse events (AE)s(During study participation)
- Serious AEs (SAE)s(During study participation)
- Changes in safety laboratory assessments(During study participation)
- Withdrawals due to AEs(During study participation)
- PK profile of C21 in subjects with COVID-19(Will be assessed on visit 2)
- Proportion of subjects discharged from hospital and free of supplemental oxygen at Days 8, 22 and 29.(Will be assessed on days 8, 22 & 29)
- Proportion of hospitalized subjects on non-invasive, invasive mechanical ventilation, extra corporeal membrane oxygenation (ECMO) or supplemental oxygen use at Days 8, 15, 22, 29 and 60.(Will be assessed on days 8, 15, 22, 29 & 60)
- Proportion of subjects in each category of the 8-point ordinal scale at Days 8, 15, 22, 29 and 60(Will be assessed on days 8, 15, 22, 29 & 60)
- Duration of hospitalization, including re-hospitalization, up to Day 60(Will be assessed upto days 60)
- Change from baseline in peripheral capillary oxygen saturation (SpO2) / fraction of inspired oxygen (FiO2) at Day 15(Will be assessed on days 15)
- Change from baseline in CRP at Day 15(Will be assessed on days 15)
- Proportion of subjects needing intensive care unit stay at Days 8, 15, 22, 29 and 60(Will be assessed on days 8, 15, 22, 29 & 60)
- Duration of intensive care unit stay, including re-admission, up to Day 60.(Will be assessed upto days 60)
- Proportion of subjects on invasive mechanical ventilation or ECMO at Days 8, 15, 22, 29 and 60, and duration of use up to Day 60.(Will be assessed upto days 60)
- Proportion of subjects free of respiratory failure at Days 8, 22, 29 and 60, and respiratory failure free days up to Day 60.(Will be assessed upto days 60)
- All-cause mortality up to Days 8, 15, 22 and 29(Will be assessed upto days 29)
- Change from baseline in lactate dehydrogenase (LDH) at Day 15(Will be assessed on days 15)
研究者
研究点 (19)
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