Evaluation of the Efficacy and Safety of Zinc in Viral Infections

SARS-CoV2 Infection Clinical Trial

— VIZIR  

Official title:

Evaluation of the Efficacy and Safety of Zinc in Viral Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212480
• Other study ID #: VIZIR.COV
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: May 4, 2022

Study information

• Verified date: March 2023
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• SARS-CoV2 Infection
• Virus Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	EPS Fattouma Bourguiba Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate.	death rate	30 days
Primary	need for ICU admission	Number of participants admitted to the Intensive care unit (ICU)	30 days
Primary	Combined_outcome	Death and/ or need for admission to the ICU for COVID-19 related complications.	30 days
Primary	treatment safety	rate of adverse events	30 days
Secondary	Need for hospitalization for patients followed up at home	Need for hospitalization for patients followed up initially at home	30 days
Secondary	lenghth of stay in Hospital	days spent at hospital for patients followed up initially at home	30 days
Secondary	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
Secondary	need for oxygen therapy	Number of participants who needed oxygen therapy	30 days