Evaluation of the Efficacy and Safety of Zinc in Viral Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- need for ICU admission
研究概览
简要总结
The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..
详细描述
The VIZIR study is a national, longitudinal, multi-centre study conducted over a 3-month follow-up period.
The priori hypothesis was that supplementation with zinc would reduce 30-day mortality and need to intensive care unit (ICU) admission among non critically ill patients with Covid-19.
The VIZIR study will be carried out in Tunisia at the level of consultations of general practitioners of both sectors : public and liberal, as well as in the emergency services of Monastir and Sousse.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
After initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either Zinc or Placebo as detailed above according to the predetermined randomization. Patients enrolled in the zinc group received 25 mg of zinc twice a day for 15 days. Patients enrolled in the placebo group received 1 capsule twice a day for 15 days.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and over .
- •Sars-Cov2 infection Diagnosed with RT PCR , Rapid Test or Chest CT-Scan performed within the less than 5 days of symptoms.
排除标准
- •Patients who received zinc before the start of the protocol.
- •heart, liver, malignancies, or renal failure (estimated glomerular filtration rate ≤30 mL/min/1.73 m2);
- •Mental disorders .
- •Chronic Dialysis.
- •Hospitalisation in ICU (use of respiratory or cardiovascular organ support (oxygen delivered by high-flow nasal cannula, noninvasive or invasive mechanical ventilation, or the use of vasopressors or inotropes). .
- •Known hypersensitivity to zinc.
- •unsuitability for oral administration
结局指标
主要结局
need for ICU admission
时间窗: 30 days
Number of participants admitted to the Intensive care unit (ICU)
treatment safety
时间窗: 30 days
rate of adverse events
Mortality rate.
时间窗: 30 days
death rate
Combined_outcome
时间窗: 30 days
Death and/ or need for admission to the ICU for COVID-19 related complications.
次要结局
- Need for hospitalization for patients followed up at home(30 days)
- resolution of COVID-19 symptoms(30 days)
- lenghth of stay in Hospital(30 days)
- need for oxygen therapy(30 days)
研究者
Pr. Semir Nouira
professor
University of Monastir