SARS-CoV2 Infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTZinc
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate. | 30 days | death rate |
| need for ICU admission | 30 days | Number of participants admitted to the Intensive care unit (ICU) |
| Combined_outcome | 30 days | Death and/ or need for admission to the ICU for COVID-19 related complications. |
| treatment safety | 30 days | rate of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for hospitalization for patients followed up at home | 30 days | Need for hospitalization for patients followed up initially at home |
| lenghth of stay in Hospital | 30 days | days spent at hospital 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 . |
| need for oxygen therapy | 30 days | Number of participants who needed oxygen therapy |
Countries
Tunisia
Outcome results
None listed