Evaluation of the Efficacy and Safety of Zinc in Viral Infections

Study Overview
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Brief Summary
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The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy and Safety of Zinc in Viral Infections

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Dietary Supplement: Zinc
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zinc arm<br>patients received a pill containing 25 mg of zinc twice a day for 15 days | Dietary Supplement: Placebo<br>* For each patient included, a prescription of an identical to the intervention arm concerning shape, smell, taste and color pill of placebo . This dose of zinc is to be taken away from meals.<br>|
| Placebo Comparator: Placebo<br>patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days | Dietary Supplement: Zinc<br>* For each patient included, a prescription regimen of zinc (in bisglycinate form) is proposed at a dose of 25 mgtwice a day for 15 days for the intervention arm. This dose of zinc is to be taken away from meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate. | death rate | 30 days | 
| need for ICU admission | Number of participants admitted to the Intensive care unit (ICU) | 30 days | 
| Combined_outcome | Death and/ or need for admission to the ICU for COVID-19 related complications. | 30 days | 
| treatment safety | rate of adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hospitalization for patients followed up at home | Need for hospitalization for patients followed up initially at home | 30 days | 
| lenghth of stay in Hospital | days spent at hospital for patients followed up initially at home | 30 days | 
| resolution of COVID-19 symptoms | Time to resolution of COVID-19 symptoms [ Evaluated at day 15 and day 30 precising the Time at which the patient is completely symptom free and severity of symptoms . | 30 days | 
| need for oxygen therapy | Number of participants who needed oxygen therapy | 30 days |