CTRI/2021/06/034015招募中3 期
A Multi-Centre, Prospective, Open Label, Parallel, Randomized, Clinical Trial toAssess the Efficacy And Safety Of Molnupiravir 800 Mg Capsules And Standard of Care (SoC) Compared To Standard of Care (SoC) Only In Mild Patients With Polymerase Chain Reaction (PCR)Confirmed COVID-19.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,220
- 试验地点
- 25
- 主要终点
- Rate of hospitalization from randomization up to day 14.
研究概览
简要总结
To evaluate the efficacy of Molnupiravir compared to standard of care in confirmed RT PCR positive patients with mild COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
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 willing and able to provide voluntary written informed consent and to follow the protocol requirements.
- •Male or female patients between 18 and 60 years of age (both inclusive).
- •Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected ≤5 days prior to randomization) Patients with mild COVID-19 (non-hospitalized) and have following symptoms and signs within 3 to 5 days prior to randomization.
- •Patients having mild COVID-19 with a score of 2 or 3 on the 10-point ordinal scale of clinical status Patients who are able to consume oral medications.
- •Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Females who are not pregnant or breastfeeding.
排除标准
- •Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator.
- •Uncontrolled comorbid medical conditions.
- •Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation.
- •If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient.
- •If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.
- •If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
- •Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
- •Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, oseltamivir or any other anti-viral treatments) during study participation as per investigator’s discretion.
- •A baseline heart rate of < 60 beats per minute at rest If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents.
结局指标
主要结局
Rate of hospitalization from randomization up to day 14.
时间窗: Rate of hospitalization from randomization up to day 14.
次要结局
- Rate of hospitalization from randomization up to day 28.(Proportion of patients with clinical improvement at the end of treatment day 10 and 14.)
研究者
研究点 (25)
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