Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT04751669
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
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
Study:
NCT04751669
Study Brief:
Protocol Section:
NCT04751669