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The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc arm | Active Comparator | patients received a pill containing 25 mg of zinc twice a day for 15 days |
|
| Placebo | Placebo Comparator | patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouira A semir, Pr | emergency department of Fattouma Bourguiba Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPS Fattouma Bourguiba Monastir | Monastir | 5000 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36367144 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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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.
| 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. |
|
| 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 .](streamdown:incomplete-link) | 30 days |
| need for oxygen therapy | Number of participants who needed oxygen therapy | 30 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008670 |
| Metals |