CTRI/2021/06/033992进行中（未招募）3 期
A prospective, randomized, parallel, multicentric, phase III clinical trial to assess the efficacy and safety of Molnupiravir 800 mg capsules and standard of care (soc) compared to standard of care (soc) only in patients with polymerase chain reaction (RT-PCR) confirmed Mild Covid-19 infection.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,218
- 试验地点
- 29
- 主要终点
- To evaluate the efficacy of Molnupiravir to standard of care in confirmed RT-PCR positive patients with Mild COVID-19
研究概览
简要总结
This is a randomized, parallel, multicenter Phase III study. The purpose of this study to estimate Molnupiravir efficacy and safety in COVID-19 patients.
In study duration: Total expected study duration will be approximately 28 days consisting of: Screening period: -3 days (-72 hours) prior to randomization.
Treatment period: 5 days
End of treatment assessment: Day 5 (+1) or at the time of early discontinuation
Post treatment follow-up: Day 10, Day 14 (+1) and Day 28 (+1)
Note: If RT-PCR test is found to be positive for Day 5(+1) sample, the test may be repeated further at Day 10 and on Day 14 (+1), if found positive on Day 10.
Total study participation duration for all the patients will till Day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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.Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements.
- •2.Male or female patients between 18 and 60 years of age (both inclusive).
- •3.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected ≤5 days prior to randomization) Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization.
- •4.Patients with mild COVID-19 and have following symptoms and signs prior to randomization.
- •Mild: Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia.
- •5.Patients who are able to consume oral medications.
- •6.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception.
- •7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.
排除标准
- •1.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.
- •2.Uncontrolled comorbid medical conditions.
- •3.Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization.
- •4.Patient is on dialysis or has reduced estimated glomerular filtration rate (73m2eGFR) <30 mL/min/1 by the Modification of Diet in Renal Disease (MDRD) equation.
- •5.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.
- •6.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.
- •7.If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization.
- •8.Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis.
- •9.Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigator’s discretion.
- •10.A baseline heart rate of < 60 beats per minute at rest.
- •11.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
To evaluate the efficacy of Molnupiravir to standard of care in confirmed RT-PCR positive patients with Mild COVID-19
时间窗: Day 1 to Day 5 | RT-PCR will be evaluated on screening, end of treatment day (plus 1) or at the time of early discontinuation. | Note: If RT-PCR test is found to be positive for Day 5 (plus 1) sample, the test may be repeated on Day 10 and on Day 14, if it was positive on Day 10 | Post treatment follow-up Day 10, Day 14(plus 1 Day), 28 Day ( plus 1 Day) | Rate of hospitalization from randomization up to day 14
次要结局
- Mortality Rate.(At day 28)
- Incidence and severity of TEAEs (clinical and laboratory)(During the study.)
- Proportion of patients discontinued the study drug due to adverse events(During the study)
- Rate of hospitalization(Randomization up to Day 28)
- Mortality rate(Day 14)
- Proportion of patients with clinical improvement(End of treatment, Day 10 and 14)
- Time to clinical improvement(from randomization up to Day 14)
- Rate of SARS-CoV2 RT-PCR negativity in nasopharyngeal and/or oropharyngeal swab(End of treatment, Day 10 and Day 15)
- Change in SARSCoV-2 viral load (Cycle Threshold (CT) value of RT-PCR test)(From Baseline to end of treatment)
研究者
研究点 (29)
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