Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial — CoVIT  

Covid19 Clinical Trial

Official title: Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04751669
• Study type: Interventional
• Source: Fundació Institut Germans Trias i Pujol
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Completion date: October 26, 2023