A Prospective, Randomized, Parallell, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 1,282
- 试验地点
- 5
- 主要终点
- Proportion of patients with clinical improvement at Day fourteen
研究概览
简要总结
The objective of the study is to evaluate theefficacy of Molnupiravir Capsule compared to standard of care in confirmedRT-PCR positive patients with moderate Coronavirus Disease of 2019 (COVID-19).
Primary Objective:
To evaluate the efficacy ofMolnupiravir Capsule compared to standard of care in confirmed RT-PCR positivepatients with moderate Coronavirus Disease of 2019 (COVID-19).
Secondary Objective:
To evaluate the safety ofMolnupiravir compared to standard of care in confirmed RT-PCR positive patientswith moderate Coronavirus Disease of 2019 (COVID-19).
Thisis a randomized, multicentric, parallel, open-label, phase III clinical studyfor evaluating the efficacy and safety of Molnupiravir combined withstandard of care compared to standard of care alone in adult Indian patientswith mild Coronavirus Disease of 2019 (COVID-19). This is a parallel study in which eligible patients will be randomized1:1 ratio into Test: Reference arm. Patients in Test arm will receive Molnupiravir 800mg (4 capsules of 200 mg) plus standard of care while the reference arm will receivestandard of care alone.
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
- •1.Male or female subjects of 18 years to 60 years age (both inclusive) 2.Subject and/or his/her legally accepted representative willing to give written informed consent.
- •3.Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization).
- •4.Subjects having moderate COVID-19 as per MoH & FW guidelines on “Clinical Management Protocol: COVID-19†as updated from time to time.
- •oModerate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 ≤93% (range 90-93%) on room air, respiratory rate more or equal to 24 per minute.
- •(Time for symptom onset and baseline should be no more than 10 days).
排除标准
- •1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient.
- •2.Subjects with severe COVID-19: severe pneumonia.
- •with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90%.
- •3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl)<30ml/min).
- •4.Subjects with oxygen saturation (SPO2) below 90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg. 5.Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Molnupiravir.
- •6.Pregnant or breast-feeding subjects will be excluded.
- •7.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
- •8.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening.
- •9.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV); cancer requiring chemotherapy within the preceding 6 months; unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
- •10.Subject has a history of alcohol or drug abuse in the previous 6 months.
- •11.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- •12.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
- •14.Participated in any other clinical trial or taken investigational drug within 1 month.
结局指标
主要结局
Proportion of patients with clinical improvement at Day fourteen
时间窗: Proportion of patients with clinical improvement at Day fourteen
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 swab and/or oropharyngeal swab(End of treatment, Day 14 and Day 28)
- Change in SARS CoV2 viral load (Cycle Threshold (CT) value of RT-PCR test)(From baseline to end of treatment, Day 14 and Day 28)
- Proportion of patients discontinued the study drug due to adverse event(All the visits)
- Incidence and severity of TEAEs (clinical and laboratory)(All the visits)