Use of a Hypochlorous Acid Spray Solution in the Treatment of COVID-19 Patients : COVICONTROL Study .
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- the change in viral load
研究概览
简要总结
The objective is To evaluate the efficacy and safety of nasal spray and mouth spray application with hypochlorous acid-containing solution versus placebo as a curative treatment for hospitalized SARS-CoV-2 positive patients And for symptomatic SARS-CoV-2 positive patients followed as outpatients
详细描述
The COVICONTROL study is a prospective, multicenter study . It is a randomized, controlled, double-blind study.
The COVICONTROL study will be conducted in Tunisia at the COVID patient management centers in the emergency departments of Monastir (Fattouma Bourguiba) and Sousse (Hospital Of Sahloul).
After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either A spray of solution containing hypochlorous acid or Placebo as detailed above according to the predetermined randomization.
For each patient included, one nasal spray in each nasal nostril /3 hours and two oral sprays/3 hours either by a solution of hypochlorous acid (NEED DEFENDER) or by a placebo. for 5 days None of the treating physician or nurses are aware about the nature of medication receive. In both arms, patients can receive antipyretics, antibacterials, antivirals, antifungals and anti-inflammatories at the discretion of the treating physician.
* Patients follow-up :
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of allergy to hypochlorous acid solution .
- •Oral lesions contraindicating the use of hypochlorous acid solution.
- •Patients receiving any other investigational agent in a clinical trial.
- •Intubated patient on mechanical ventilation or with uncontrolled disease : congestive heart failure, IDM, uncontrolled epilepsy or psychiatric illness.
- •Uncertain patient follow-up during the study.
结局指标
主要结局
the change in viral load
时间窗: 3 days
The primary endpoint in all included patients (outpatients and inpatients ) is the change in viral load between Day 1 and Day 3
次要结局
- Death(30 days)
- Duration of symptoms(30 days)
- Hospitalization Need for hospitalization.(30 days)
- Need for ventilatory support(30 days)
- Contamination(30 days)
- Need for intensive care.(30 days)
研究者
Pr. Semir Nouira
Pr Semir Nouira , Head of Emergency department , Fattouma Bourguiba Hospital
University of Monastir