Evaluation of the Efficacy and Safety of Zinc in Viral Infections

Not Applicable

Completed

• Conditions: SARS-CoV2 Infection
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Zinc

• Registration Number: NCT05212480
• Lead Sponsor: University of Monastir

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-15
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc arm	Placebo	patients received a pill containing 25 mg of zinc twice a day for 15 days
Placebo	Zinc	patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Need for hospitalization for patients followed up at home	30 days	Need for hospitalization for patients followed up initially at home
resolution of COVID-19 symptoms	30 days	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 .
lenghth of stay in Hospital	30 days	days spent at hospital for patients followed up initially at home
need for oxygen therapy	30 days	Number of participants who needed oxygen therapy

Trial Locations

Locations (1)

EPS Fattouma Bourguiba Monastir; 🇹🇳 Monastir, Tunisia