NCT05212480

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

January 7, 2022

Last Update Submit

March 13, 2023

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (4)

  • Need for hospitalization for patients followed up at home

    30 days

  • lenghth of stay in Hospital

    30 days

  • resolution of COVID-19 symptoms

    30 days

  • need for oxygen therapy

    30 days

Study Arms (2)

Zinc arm

ACTIVE COMPARATOR

patients received a pill containing 25 mg of zinc twice a day for 15 days

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

Dietary Supplement: Zinc

Interventions

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.

Placebo
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.

Zinc arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPS Fattouma Bourguiba Monastir

Monastir, 5000, Tunisia

Location

Related Publications (1)

  • 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.

    PMID: 36367144DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Zinc

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Nouira A semir, Pr

    emergency department of Fattouma Bourguiba Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 28, 2022

Study Start

February 15, 2022

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

TU(1)