EUCTR2020-002106-68-GB进行中（未招募）1 期
Favipiravir, lopinavir/ritonavir or combination therapy: a randomised, double blind, 2x2 factorial placebo-controlled trial of early antiviral therapy in COVID-19 - FLARE
niversity College London Comprehensive Clinical Trial Unit0 个研究点目标入组 240 人开始时间: 2020年7月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Key workers (see definition in Appendix 2) and their household members with the following:
- •o Symptoms compatible with COVID-19 disease (Fever >37.8oC on at least one occasion AND either cough and/ or anosmia) within the first 5 days of symptom onset (date/time of enrolment must be within the first 5 days of symptom onset)
- •o OR ANY symptoms compatible with COVID-19 disease (may include, but are not limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza) and tested positive for SARS-CoV-2 within the first 7 days of symptom onset (date/time of enrolment must be within the first 7 days of symptom onset)
- •o OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours (date/time of test must be within 48 hours of enrolment)
- •2. Male or female aged 18 years to 70 years old inclusive at screening
- •3. Willing and able to take daily saliva samples
- •4. Able to provide full informed consent and willing to comply with trial-related procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Known hypersensitivity to any of the active ingredients or excipients in favipiravir and matched placebo, and in lopinavir/ritonavir and matched placebo (See Appendix 3)
- •2. Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known elevation of liver aminotransferases with AST or ALT > 3 X ULN)*
- •3. Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m2*
- •4. HIV infection, if untreated, detectable viral load or on protease inhibitor therapy
- •5. Any clinical condition which the investigator considers would make the participant unsuitable for the trial
- •6. Concomitant medications known to interact with favipiravir and matched placebo, and with lopinavir/ritonavir and matched placebo, and carry risk of toxicity for the participant (See Appendix 4)
- •7. Severe illness requiring hospitalisation
- •8. Pregnancy and/ or breastfeeding
- •9. Eligible female participants of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraceptive measures during the trial and within the time point specified following last trial treatment dose.
- •10. Participants enrolled in any other interventional drug or vaccine trial (co-enrolment in observational studies is acceptable).
- •* Considering the importance of early treatment of COVID-19 to impact viral load, the absence of chronic liver/ kidney disease will be confirmed verbally by the participant during pre-screening and Screening/Baseline visit. Safety blood samples will be collected at Screening/Baseline visit (Day 1) and test results will be examined as soon as they become available within 24 hours.
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