TCTR20230111009已完成2 期
A randomized open-label trial to compare the efficacy and safety of favipiravir and molnupiravir in adults with mild to moderate COVID-19 and increased risk of disease severity
ational Science and Technology Development Agency (NSTDA)0 个研究点目标入组 977 人开始时间: 2023年1月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 977
研究概览
简要总结
In this large outpatient population already immunized and mostly infected with the omicron variant, pulmonary involvement was less common with molnupiravir than with favipiravir but rates of pulmonary involvement and of other adverse outcomes were much lower than anticipated in both arms. There were no differences in the risk of death or COVID-19 related hospitalization.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •Age equal to 18 years or more
- •Initial onset of signs/symptoms attributable to COVID-19 for 5 days or less prior to the day of randomization
- •At least 1 sign/symptom attributable to COVID-19 on the day of randomization
- •Mild or moderate COVID-19 (non severe COVID-19)
- •Positive SARS-CoV-2 RT-PCR or antigenic test (ATK) for 5 days or less (if enrollment based on ATK test result, specimen collection is needed for further confirmation with RT-PCR)
- •At least 1 underlying medical condition associated with an increased risk of severe illness from COVID-19 among the following conditions:
- •- Age equal to 60 years or more
- •- Asthma, mild, moderate to severe
- •- Bronchiectasis (thickening of the lungs airways)
- •- Bronchopulmonary dysplasia (chronic lung disease affecting newborns)
- •- Chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis
- •- Pulmonary embolism
- •- Pulmonary hypertension
- •- Previous pulmonary tuberculosis (after recovery)
- •- Current smoking
- •- Major thalassemia
- •- Hypertension
- •- Coronary heart disease
- •- Chronic kidney disease (CKD)
- •- Chronic liver disease (including cirrhosis CHILD class A (well-compensated disease) or class B (significant functional compromise) if no risk of study treatment toxicity
- •- Hepatocellular carcinoma if no risk of study treatment toxicity
- •- Diabetes (type 1 or type 2)
- •- HIV infection
- •- Congenital immunocompromised conditions
- •- Condition or medications that weaken their immune system (i.e., current corticoid treatment)
- •- Body Mass index (BMI) equal to 30 kg/m2 or more
- •- Recent Pregnancy if not breastfeeding
- •- Alcohol or other substance use disorders, if not likely to affect adherence
排除标准
- •- Currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization
- •- Patient with pulmonary involvement as defined in the protocol
- •- Use of monoclonal antibodies planned at time of randomization
- •- Active tuberculosis
- •- Recent stroke or cerebrovascular disease which affects blood flow to the brain
- •- For women: pregnancy, breastfeeding or unwillingness to use contraception during the intervention period and for at least one week after completion of the study treatment
- •- For men: unwillingness to use a reliable method of birth control (contraception) during study treatment with molnupiravir and for at least 3 months after the last dose
- •- Dialysis or estimated glomerular filtration rate <30 ml/min per 1.73 m2
- •- Hypersensitivity or other contraindication to the drugs
- •- 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, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of the study treatment. Examples: patient who recently started chemotherapy, or chronic use of antacid.
研究者
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