Evaluation of the Efficacy and Safety of Zinc in Viral Infections (VIZIR)

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Zinc

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 Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • EPS Fattouma Bourguiba Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zinc arm; patients received a pill containing 25 mg of zinc twice a day for 15 days	Dietary supplement: Placebo; 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.
Placebo Comparator: Placebo; patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days	Dietary supplement: Zinc; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira A semir, Pr, emergency department of Fattouma Bourguiba Monastir

Publications and helpful links

General Publications

• Ben Abdallah S, Mhalla Y, Trabelsi I, Sekma A, Youssef R, Bel Haj Ali K, Ben Soltane H, Yacoubi H, Msolli MA, Stambouli N, Beltaief K, Grissa MH, Khrouf M, Mezgar Z, Loussaief C, Bouida W, Razgallah R, Hezbri K, Belguith A, Belkacem N, Dridi Z, Boubaker H, Boukef R, Nouira S. Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial. Clin Infect Dis. 2023 Jan 13;76(2):185-191. doi: 10.1093/cid/ciac807. Erratum In: Clin Infect Dis. 2023 Feb 03;:

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: VIZIR.COV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No