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Completed

NCT Number: NCT05212480

Evaluation of the Efficacy and Safety of Zinc in Viral Infections

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPS Fattouma Bourguiba Monastir

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Mortality rate.

    Time frame: 30 days

    death rate

  2. need for ICU admission

    Time frame: 30 days

    Number of participants admitted to the Intensive care unit (ICU)

  3. Combined_outcome

    Time frame: 30 days

    Death and/ or need for admission to the ICU for COVID-19 related complications.

  4. treatment safety

    Time frame: 30 days

    rate of adverse events

Secondary outcomes

  1. Need for hospitalization for patients followed up at home

    Time frame: 30 days

    Need for hospitalization for patients followed up initially at home

  2. lenghth of stay in Hospital

    Time frame: 30 days

    days spent at hospital for patients followed up initially at home

  3. resolution of COVID-19 symptoms

    Time frame: 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 .

  4. need for oxygen therapy

    Time frame: 30 days

    Number of participants who needed oxygen therapy

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Acronym: VIZIR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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