A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 试验地点
- 6
- 主要终点
- Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first
研究概览
简要总结
Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.
详细描述
A prospective, randomised, open label study of the combined use of favipiravir and standard clinical care verses standard clinical care alone.
A computer-based software will randomise participants 1:1 to either receive favipiravir and standard medical care or standard medical care alone. The allocated medical regime will commence for 10 days.
Research blood, sputum nose swab and urine samples will be collected at baseline, as well as between day 5 and 10, and between day 14 and 28 to enable comparative analyses.
A COVID-19 antibody test will also be performed 14-28 days after randomisation. In the event of clinically indicated bronchoscopy taking place within 28 days of consent then additional bronchoscopy washing and brushing samples and paired blood sample will be taken for research purposes If a participant is discharged before one of the latter time points, they will be required to return to hospital (provided they are well enough) for the collection of repeat samples.
Participants will be closely monitored whilst taking the study medications. Participants will study exit at subject death or 28 days post-randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants: Signed informed consent
- •New admission to hospital for period expected to last ≥ 1 night
- •Suspected or confirmed COVID-19 infection
- •Patients are suspected of COVID-19 infection if they have the following:
- •· Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing).
- •· Finding from either a chest x-ray or CT suggestive of Covid-19 infection
- •· Alternative causes are considered unlikely
- •For women to be eligible to enter and participate in the study they should be: of non-child-bearing
- •potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- •or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method.
- •Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose
排除标准
- •Pregnant or breast feeding, due to potential teratogenicity
- •Hepatic impairment - (AST or ALT > 3.5 x upper limit of normal)
- •Presently enrolled in an interventional drug study
- •Unable to take medication via the oral or nasogastric route
- •Known sensitivity Favipiravir
研究组 & 干预措施
Favipiravir & Standard of Care
Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day
干预措施: Standard of care management (Other)
Favipiravir & Standard of Care
Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day
干预措施: Favipiravir (Drug)
Standard of care
No trial intervention
干预措施: Standard of care management (Other)
结局指标
主要结局
Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first
时间窗: Up to 28 days from randomisation
Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first The seven-category ordinal scale is : 1. Not hospitalised with resumption of normal activities 2. Not hospitalised, but unable to resume normal 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both 6. Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both 7. Death
次要结局
- Clinical status on a seven-category ordinal scale (Day 7)(Day 7 from randomisation)
- Clinical status on a seven-category ordinal scale (Day 14)(Day 14 from randomisation)
- Overall survival(28 days from randomisation)
- Time to improvement by two points on the NEWS score(Up to 28 days from randomisation)
- Time to improvement by two points on the NEWS element score for temperature(Up to 28 days from randomisation)
- Time to improvement by two points on the NEWS element score for heartrate(Up to 28 days from randomisation)
- Time to improvement by two points on the NEWS element score for respiratory rate(Up to 28 days from randomisation)
- Time to improvement by two points on the NEWS element score for oxygen saturation.(Up to 28 days from randomisation)
- Admission to intensive care(Up to 28 days from randomisation)
- Requirement for mechanical ventilation(Up to 28 days from randomisation)
- Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen(Up to 28 days from randomisation)
- Incidence of bacterial or fungal infection(Up to 28 days from randomisation)
- Incidence of adverse events not directly caused by COVID-19 infection.(Up to 28 days from randomisation.)