CTRI/2021/05/033864Other3 期
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
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 ââ?¬Å?Clinical Management Protocol: COVID-19ââ?¬? 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 ââ?°Â¤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) ââ?°Â¤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.
- •13.Anticipated transfer to another hospital which is not a study site within 72 hours.
- •14.Participated in any other clinical trial or taken investigational drug within 1 month.
研究者
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