A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Moderate COVID 19
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 1,282
- 试验地点
- 15
- 主要终点
- Proportion of patients with clinical improvement
研究概览
简要总结
This is a randomized, multicentric, parallel, open-label, phase II/III clinicaltrial for evaluating the efficacy and safety of Molnupiravir combined withstandard of care compared to standard of care alone in adult Indian patientswith moderate Coronavirus Disease of 2019 (COVID-19). This is a parallel study in which eligible patients will be randomized 1:1ratio into Test: Reference arm. Patients in Test arm will receive Molnupiravir800 mg (4 capsules of200 mg) plus standard of care while the reference armwill receive standard of care alone. Study will be Conducted in Two parts: PartI – Initial phase of the study will be conducted in 100 patients and interimanalysis will be done for primary endpoint assessments. Part II – Study will be continued to completeenrolment of 1282 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged ≥18 and ≤60 years and voluntarily willing to provide signed and dated informed consent.
- •Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment)
- •Patients with moderate COVID-19 disease i.e., pneumonia with no signs of severe disease
- •For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his/her partner during the study period and for at least 28 days following the last study treatment.
排除标准
- •Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation.
- •Patients with severe disease
- •Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN
- •Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days
- •Patients with a history of acute pancreatitis within 3 months
- •Severe renal impairment [creatinine clearance (CrCl) <30 mL/min]
- •Having used Molnupiravir or participated in any other interventional clinical study within 30 days.
结局指标
主要结局
Proportion of patients with clinical improvement
时间窗: Day 14
次要结局
- Mortality rate(Day 28)
- Proportion of patients with clinical improvement(Day 28)
- Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab(End of treatment, Day 10, Day 14 and Day 28)
- Incidence and severity of TEAEs (clinical and laboratory)(All Visits)
- Proportion of patients discontinued the study drug due to adverse events(All Visits)