A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- SARS CoV2 infection
研究概览
简要总结
A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia
详细描述
Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at different levels (2 levels of exposure).
The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6.
Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Random blind allocation.
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
- 是
入选标准
- •No self-medication with chloroquine, hydroxychloroquine or antivirals
- •COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test)
- •No clinical symptoms suggestive of COVID-19
- •Having given written consent for their participation in the study
排除标准
- •Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion
- •Hypersensitivity to any of the drugs or to any of its excipients.
- •ECG showing rhythm disturbances, QT interval> 500 ms, conduction disturbances.
- •Severe hepatic impairment.
- •Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol.
- •Retinal pathology.
- •Epilepsy.
- •Myasthenia.
- •Psoriasis.
- •Methemoglobinemia.
- •Porphyria.
- •Pregnant or lactating women
- •Contraindication to the study products
研究组 & 干预措施
Hydroxychloroquine & Zinc
Will receive:
- Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
- Zinc 15 mg at daily dose up to 2 months
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine & Zinc
Will receive:
- Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
- Zinc 15 mg at daily dose up to 2 months
干预措施: Zinc (Drug)
Hydroxychloroquine
Will receive:
- Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
- Placebo of Zinc
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine
Will receive:
- Hydroxychloroquine 400 mg at day 1 and day 2, then a weekly dose of 400 mg up to 2 months.
- Placebo of Zinc
干预措施: Zinc (Placebo) (Drug)
Placebo
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
干预措施: Hydroxychloroquine (placebo) (Drug)
Placebo
Will receive a double placebo (Hydroxychloroquine and Zinc) up to 2 months
干预措施: Zinc (Placebo) (Drug)
结局指标
主要结局
SARS CoV2 infection
时间窗: At 2 months of follow-up
Frequency of confirmed SARS CoV2 infection
次要结局
- Adverse Events(each month up to 2 months)
- COVID-19 symptoms description(At 2 months of follow-up)