Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- decreasing the number of cases infected with covid 19
研究概览
简要总结
Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.
The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No self-medication with study drugs or antivirals
- •Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay
- •No signs of COVID19
- •Having given consent for the study
排除标准
- •Participation in other clinical trials aimed at primary prevention of VIDOC infection19
- •Liver failure
- •Known allergy to the study product
- •Pregnancy or breastfeeding
- •Vitamin A and E treatment in progress
研究组 & 干预措施
DOXY ZINC
Doxycycline daily dosing (100mg) Zinc daily dosing (15mg)
干预措施: Doxycyclin (Drug)
DOXY PLACEBO
Doxycycline daily dosing (100mg) placebo of Zinc
干预措施: Doxycyclin (Drug)
PLACEBO
placebo of Doxycycline daily dosing placebo of Zinc
干预措施: Doxycyclin (Drug)
结局指标
主要结局
decreasing the number of cases infected with covid 19
时间窗: WEEK 6
Determine if the use of doxyciciline low dose as preventive treatment decrease the number of cases infected with covid 19 in the active arm compared to the placebo arm. Participants for each randomized treatment arm as compared to placebo.
次要结局
- Measurement of the emergence of clincal symptoms of COVID 19(WEEK 6)
- the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo.(WEEK 6)
研究者
Hedi Gharsallah
Professor
General Administration of Military Health, Tunisia