A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Reduction in Participant Symptoms of COVID-19
研究概览
简要总结
This is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for COVID-19.
详细描述
This study will screen for the activity of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently diagnosed with COVID-19. This will be a randomized, blinded placebo-controlled study with respect to the active treatment (chlorine dioxide) vs placebo, and randomized open-label with respect to a non-prescription medication (famotidine) and supplements including zinc, EGCG and lactoferrin. Treatment will last for 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 20-70
- •Confirmed diagnosis of COVID-19 by positive COVID-19 test. Symptoms of a mild degree such that hospitalization is not required. Within 7 days of symptom onset.
- •Ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen
排除标准
- •COVID-19 symptoms of a severe enough nature that requires hospitalization
- •Pregnancy or lactation
- •Diagnosis of diabetes mellitus
- •currently taking paroxetine or digoxin
- •Individuals with diabetes mellitus
研究组 & 干预措施
placebo
1 liter of filtered water
干预措施: placebo (Other)
chlorine dioxide aqueous solution (AS)
1 liter of filtered water with AS
干预措施: chlorine dioxide (Other)
placebo with zinc acetate (ZA)
1 liter of filtered water with ZA
干预措施: zinc acetate (Dietary Supplement)
placebo with zinc acetate (ZA)
1 liter of filtered water with ZA
干预措施: placebo (Other)
AS with ZA
1 liter of filtered water with AS and ZA
干预措施: chlorine dioxide (Other)
AS with ZA
1 liter of filtered water with AS and ZA
干预措施: zinc acetate (Dietary Supplement)
placebo with famotidine, lactoferrin and green tea extract (FLG)
1 liter of filtered water with FLG
干预措施: Famotidine (Drug)
placebo with famotidine, lactoferrin and green tea extract (FLG)
1 liter of filtered water with FLG
干预措施: placebo (Other)
placebo with famotidine, lactoferrin and green tea extract (FLG)
1 liter of filtered water with FLG
干预措施: lactoferrin, green tea extract (Dietary Supplement)
AS with FLG
1 liter of filtered water with AS and FLG
干预措施: chlorine dioxide (Other)
AS with FLG
1 liter of filtered water with AS and FLG
干预措施: Famotidine (Drug)
AS with FLG
1 liter of filtered water with AS and FLG
干预措施: lactoferrin, green tea extract (Dietary Supplement)
placebo with ZA and FLG
1 liter of filtered water with ZA and FLG
干预措施: zinc acetate (Dietary Supplement)
placebo with ZA and FLG
1 liter of filtered water with ZA and FLG
干预措施: Famotidine (Drug)
placebo with ZA and FLG
1 liter of filtered water with ZA and FLG
干预措施: placebo (Other)
placebo with ZA and FLG
1 liter of filtered water with ZA and FLG
干预措施: lactoferrin, green tea extract (Dietary Supplement)
AS with ZA and FLG
1 liter of filtered water with AS, ZA, and FLG
干预措施: chlorine dioxide (Other)
AS with ZA and FLG
1 liter of filtered water with AS, ZA, and FLG
干预措施: zinc acetate (Dietary Supplement)
AS with ZA and FLG
1 liter of filtered water with AS, ZA, and FLG
干预措施: Famotidine (Drug)
AS with ZA and FLG
1 liter of filtered water with AS, ZA, and FLG
干预措施: lactoferrin, green tea extract (Dietary Supplement)
结局指标
主要结局
Reduction in Participant Symptoms of COVID-19
时间窗: 3 days
Symptoms of COVID-19 will be evaluated daily using a visual analogue scale
次要结局
- Change in Body Temperature(8 days)
- Rate of Hospitalization(28 days)
- Change in Oxygen Saturation(8 days)
- Incidence of Treatment-Emergent Adverse Events(28 days)