The DAWN Antivirals Trial: the Efficacy of Antivirals for COVID-19 Infections Presenting to Ambulatory Care: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- KU Leuven
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to first self-reported recovery within 30 days after randomisation
研究概览
简要总结
This is a prospective, placebo controlled, individually randomized controlled phase III trial in Primary Care, assessing the efficacy of antivirals, i.e. camostat and molnupiravir, in accelerating recovery in Covid-19 patients.
详细描述
In patients aged 40 years and above and diagnosed with Covid-19 upon study entry, we will evaluate the efficacy of camostat or molnupiravir on recovery within 30 days after randomisation. Participants will be randomly assigned to camostat, molnupiravir or placebo using a computer generated randomisation process. Participants will be treated for 7 days in case of camostat and 5 days in case of molnupiravir, and follow-up will be 30 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be masked for camostat or placebo, molnupiravir is open label
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 years or older;
- •At least 2 Covid-19 suggestive symptoms at the time of inclusion, with onset of a maximum of 5 days prior to enrolment, and which cannot be explained by an alternative cause, and defined by the current Sciensano case definition
- •Positive result on PCR test or rapid Ag test in the 7 days before inclusion or at the time of inclusion;
- •Patient is community dwelling;
- •Participant or their proxy is willing and able to give informed consent for participation in the trial;
- •Participant is willing to comply with all trial procedures.
排除标准
- •Hospital admission is required at the time of possible recruitment;
- •Positive PCR or rapid antigen test for SARS-CoV-2 in the last 2 months other than a test at recruitment or in the 7 days prior to recruitment;
- •Participating in any other interventional drug clinical study before enrolment in the study;
- •Breastfeeding;
- •Known severe neurological disorder, especially seizures in the last 12 months;
- •Known allergy to camostat or molnupiravir;
- •Previous adverse reaction to, or currently taking, camostat or molnupiravir;
- •Patients in palliative care;
- •Pregnant women or women of childbearing potential who may become pregnant during the trial and don't agree to use any of the effective contraceptive measures lised above;
- •Judgement of the recruiting clinician deems participant ineligible.
研究组 & 干预措施
Camostat
4 x 200 milligram per day for 7 days
干预措施: Camostat (Drug)
Placebo
4 x per day for 7 days
干预措施: Placebo (Drug)
Molnupiravir
2 x 800 milligram per day for 5 days
干预措施: Molnupiravir (Drug)
结局指标
主要结局
Time to first self-reported recovery within 30 days after randomisation
时间窗: within 30 days after randomisation
次要结局
- All-cause unplanned hospital admission for at least 24 hours(within 30 days after randomisation)
- All-cause mortality(within 30 days after randomisation)
- Health status(at 8 days and 30 days after randomization)
- Oxygen administration in the home setting(over a period of 30 days after randomization)
- All-cause mortality at 1 year after randomization(at 1 year)
- Cardiovascular and thromboembolic complications(within 7 days and 30 days after randomization)
- Symptom duration for each individual symptom(over a period of 30 days after randomization)
- Duration of hospital admission for those admitted to hospital(over a period of 30 days after randomization)
- Health services usage(over a period of 30 days after randomization)
- Consumption of antibiotics(over a period of 30 days after randomisation)
- Participants' quality of life(at 7 days and 30 days after randomization)
- Time to sustained recovery within 14 days(within 30 days after randomisation)
- At least once ventilated(over a period of 30 days after randomization)
- Admission to ICU(over a period of 30 days after randomization)
- All-cause unplanned hospital admission for at least 24 hours or all-cause mortality within 30 days of randomization(over a period of 30 days after randomization)