Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT04751669
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2021-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial
Sponsor:
Fundació Institut Germans Trias i Pujol
Organization:
Study Overview
Official Title:
Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoVIT
Brief Summary:
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid.
We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid
We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid
Detailed Description:
* Type of study/ Design: Randomized, double-blind, placebo-controlled clinical trial.
* Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
* Title of the clinical trial: Efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and Long Covid: A double-blind, placebo-controlled, randomized clinical trial.
* Protocol code: CoVIT Clinical Trial
* NºClinicaltrials.gov: Pending
* Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
* Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
* Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
* Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
* Study treatments: Dietary supplement with micronutrients and Placebo
* Test phase: Not applicable.
* Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection, and incidence of Long Covid.
* Study pathology: COVID-19.
* Main variable: The need for hospital admission of SARS-CoV-2 documented infection and the incidence of Long Covid
* Study population and total number of patients: Patients of the health system of the Northern Metropolitan Area of Catalan Health Institution with symptoms compatible with SARS-CoV-2 infection. A total of 300 people (150 treated with dietary supplement and 150 with placebo).
* Duration of treatment: 14 days.
* Patients follow-up: 180 days
* Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
* Title of the clinical trial: Efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and Long Covid: A double-blind, placebo-controlled, randomized clinical trial.
* Protocol code: CoVIT Clinical Trial
* NºClinicaltrials.gov: Pending
* Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
* Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
* Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
* Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
* Study treatments: Dietary supplement with micronutrients and Placebo
* Test phase: Not applicable.
* Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection, and incidence of Long Covid.
* Study pathology: COVID-19.
* Main variable: The need for hospital admission of SARS-CoV-2 documented infection and the incidence of Long Covid
* Study population and total number of patients: Patients of the health system of the Northern Metropolitan Area of Catalan Health Institution with symptoms compatible with SARS-CoV-2 infection. A total of 300 people (150 treated with dietary supplement and 150 with placebo).
* Duration of treatment: 14 days.
* Patients follow-up: 180 days
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: