A Prospective, Randomized, Parallel, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,218
- 试验地点
- 18
- 主要终点
- To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).
研究概览
简要总结
Molnupiravir is an antiviral drug acts as an analogue to Covid 19 virus RNA . By inserting incorrect sequence in viral RNA it creates incorrect copies of viral RNA, resulting in decreased or no viral infection in the patients.
The Proposed study is planned to evaluate efficacy and safety of Molnupiravir is 200 mg capsule in mild Covid 19 patients. Total 1218 patients will be enrolled in the study in two arms in 1: 1 ratio. 609 mild Covid 19 positive patients will be enrolled in the study. The given treatment will be known to patients and the study investigators. 4 capsules of 200 mg twice daily along with SOC will be administered to the patients in IP arm for 5 days. In other arm patients will receive only SOC for Covid 19 as per Indian regulatory guidelines. Total duration of participation in the study is for 28 days for each patient.
Subjects will be enrolled after obtaining consent form. 6 study visits are planned in the study, screening, baseline, day 5, day 10, day 14 and day 28. Efficacy analysis will be performed considering the parameters like Complete Blood Count (CBC);Liver Function Test: SGOT, SGPT, Total Bilirubin ;Renal Function Test: Serum Creatinine and eGFR, BUN; Random Blood glucose; D-dimer; C-reactive protein, RT PCR, ECG.
Safety Parameters will be assessed by evaluating TEAE and abnormal lab investigation readings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Male or female subjects of 18 years to 60 years both inclusive
- •Subject and/or his/her legally accepted representative willing to give written informed consent.
- •Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RTPCR (within 48 hours prior to randomization).
- •4 Subjects having mild grade of COVID-19 as per MoH & FW guidelines on “Clinical Management Protocol: COVID-19†as updated from time to time.
- •Mild COVID-19: Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache, without evidence of breathlessness or hypoxia (normal saturation).
- •(Time for symptom onset and baseline should be no more than 7 days).
排除标准
- •1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient.
- •2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute 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.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.
- •5.Pregnant or breast-feeding subjects will be excluded.
- •6.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).
- •7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening.
- •8.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.
- •9.Subject has a history of alcohol or drug abuse in the previous 6 months.
- •10.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- •11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
- •13.Participated in any other clinical trial or taken investigational drug within 1 month.
- •14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the subject’s safe participation in and completion of the study.
结局指标
主要结局
To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).
时间窗: -Rate of hospitalization from randomization up to Day 14
次要结局
- Evaluate the safety of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).(-Rate of hospitalization from randomization up to Day 28)