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

Primary Purpose

SARS-CoV2 Infection

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Zinc
Placebo
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV2 Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EPS Fattouma Bourguiba Monastir

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zinc arm

Placebo

Arm Description

patients received a pill containing 25 mg of zinc twice a day for 15 days

patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Need for hospitalization for patients followed up at home
Need for hospitalization for patients followed up initially at home
lenghth of stay in Hospital
days spent at hospital for patients followed up initially at home
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 .
need for oxygen therapy
Number of participants who needed oxygen therapy

Full Information

First Posted
January 7, 2022
Last Updated
March 13, 2023
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT05212480
Brief Title
Evaluation of the Efficacy and Safety of Zinc in Viral Infections
Acronym
VIZIR
Official Title
Evaluation of the Efficacy and Safety of Zinc in Viral Infections
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc arm
Arm Type
Active Comparator
Arm Description
patients received a pill containing 25 mg of zinc twice a day for 15 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality rate.
Description
death rate
Time Frame
30 days
Title
need for ICU admission
Description
Number of participants admitted to the Intensive care unit (ICU)
Time Frame
30 days
Title
Combined_outcome
Description
Death and/ or need for admission to the ICU for COVID-19 related complications.
Time Frame
30 days
Title
treatment safety
Description
rate of adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Need for hospitalization for patients followed up at home
Description
Need for hospitalization for patients followed up initially at home
Time Frame
30 days
Title
lenghth of stay in Hospital
Description
days spent at hospital for patients followed up initially at home
Time Frame
30 days
Title
resolution of COVID-19 symptoms
Description
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 .
Time Frame
30 days
Title
need for oxygen therapy
Description
Number of participants who needed oxygen therapy
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira A semir, Pr
Organizational Affiliation
emergency department of Fattouma Bourguiba Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPS Fattouma Bourguiba Monastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
36367144
Citation
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;:
Results Reference
derived

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Evaluation of the Efficacy and Safety of Zinc in Viral Infections

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