CTRI/2021/08/035424尚未招募3 期
A Phase 3, Prospective, Open Label, Randomized, Multicenter, Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with Moderate COVID-19 disease - Version 2.0, Dated 08.06.2021
Aurobindo Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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 and/or female patients aged >= 18 and <= 60 years of age (both inclusive).
- •2.Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent.
- •3.Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization.
- •4.Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization.
- •a. Respiratory rate >= 24/min, breathlessness
- •b. SpO2: 90% to <= 93% on room air
- •5.Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on).
- •6.Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit.
- •7.Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization.
- •Medically acceptable forms of contraceptive include:
- •a.Hormonal contraceptives (at least 1 month before screening visit)
- •b.Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide)
- •c.Intrauterine device (IUD)
排除标准
- •Inclusion Criteria:
- •1.Male and/or female patients aged >= 18 and <= 60 years of age (both inclusive).
- •2.Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent.
- •3.Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization.
- •4.Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization.
- •a. Respiratory rate >= 24/min, breathlessness
- •b. SpO2: 90% to <= 93% on room air
- •5.Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on).
- •6.Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit.
- •7.Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization.
- •Medically acceptable forms of contraceptive include:
- •a.Hormonal contraceptives (at least 1 month before screening visit)
- •b.Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide)
- •c.Intrauterine device (IUD)
- •Exclusion Criteria:
- •1. Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs.
- •2.Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization.
- •3.Patients infected post vaccination of either 1st or 2nd dose.
- •4.Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization.
- •5.Patient with severe COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen >=0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO).
- •6.Patients have 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.
- •7.Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization.
- •8.Patients with AIDS-defining illness in the past 6 months.
- •9.Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigatorâ??s discretion.
- •10.Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation.
- •11.Patients with Absolute Neutrophil Count (ANC) < 500 mm3.
- •12.Patients currently administering immunosuppressive
研究者
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