SARS-CoV2 InfectionVIZIRNCT05212480
Evaluation of the Efficacy and Safety of Zinc in Viral Infections
A study testing Zinc in people with SARS-CoV2 Infection, run by University of Monastir at 1 site in Tunisia.
Trial summary
The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients.. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Feb 2022to 4 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..
Read the 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.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Zinc, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Zinc arm | Active comparator | patients received a pill containing 25 mg of zinc twice a day for 15 days Receives: Dietary Supplement: Placebo |
| Placebo | Placebo comparator | patients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days Receives: Dietary Supplement: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate.
death rate
Measured: 30 days
need for ICU admission
Number of participants admitted to the Intensive care unit (ICU)
Measured: 30 days
Combined_outcome
Death and/ or need for admission to the ICU for COVID-19 related complications.
Measured: 30 days
treatment safety
rate of adverse events
Measured: 30 days
Secondary outcomes (4)
Need for hospitalization for patients followed up at home
Need for hospitalization for patients followed up initially at home
Measured: 30 days
lenghth of stay in Hospital
days spent at hospital for patients followed up initially at home
Measured: 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 .
Measured: 30 days
need for oxygen therapy
Number of participants who needed oxygen therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Feb 2022
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira A semir, Pr, Principal investigator, emergency department of Fattouma Bourguiba Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212480
- Sponsor's protocol ID
- VIZIR.COV
- Acronym
- VIZIR
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36367144
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Zinc in Viral Infections
- ClinicalTrials.gov ID
- NCT05212480
- Acronym / sponsor ID
- VIZIR / VIZIR.COV
- Conditions
- SARS-CoV2 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc arm | Active comparator | Dietary Supplement: Placebopatients received a pill containing 25 mg of zinc twice a day for 15 days |
| Placebo | Placebo comparator | Dietary Supplement: Zincpatients received identical shape, smell, taste and color pill like the protocol treatment twice a day for 15 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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). .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincFor 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 supplement | Placebo |
| PlaceboFor 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. | Dietary supplement | Zinc arm |
Primary outcome
Mortality rate.
Time frame: 30 days
death rate
need for ICU admission
Time frame: 30 days
Number of participants admitted to the Intensive care unit (ICU)
Combined_outcome
Time frame: 30 days
Death and/ or need for admission to the ICU for COVID-19 related complications.
treatment safety
Time frame: 30 days
rate of adverse events
4 secondary outcomes
Need for hospitalization for patients followed up at home
Time frame: 30 days
lenghth of stay in Hospital
Time frame: 30 days
resolution of COVID-19 symptoms
Time frame: 30 days
need for oxygen therapy
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 36367144Ben 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira A semir, Pr principal investigator
emergency department of Fattouma Bourguiba Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with SARS-CoV2 Infection, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate. (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05212480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.