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

Fundació Institut Germans Trias i Pujol

Status: Completed

Conditions: Covid19

Treatments: Dietary Supplement: Vitamin and trace elements; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04751669

CoVIT Clinical Trial

Details and patient eligibility

About

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

Full 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

Enrollment: 252 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed Consent Form signed.
2. Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
3. Positive polymerase chain reaction (PCR) or transcription-mediated amplification (TMA) test or rapid antigen test for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) or diagnostic test available.
4. Age ≥ 18 years
5. Availability to meet the requirements of the protocol.

Exclusion criteria

1. Intake of any micronutrient supplement during the month prior to inclusion.
2. Patients fulfilling hospitalization criteria.
3. Previous allergies to the micronutrient components and excipients.
4. Age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
5. Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
6. Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
7. Any other findings that at the discretion of the researcher may compromise protocol performance or significantly influence the interpretation or results of the effects of the nutritional supplement
8. Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 2 patient groups, including a placebo group

Micronutrient dietary supplement effervescent tablet

Experimental group

Description:

Tablet containing: * Retinol (Vitamin A) 700 mcg * Cholecalciferol (Vitamin D3) 10 mcg * Alpha-Tocopherol (Vitamin E) 45 mg * Ascorbic acid (vitamin C) 1000 mg * Pyridoxine (Vitamin B6) 6.5 mg * Cyanocobalamin (Vitamin B12) 9.6 mg * Folic acid 400 mg * Iron 5 mg * Zinc 10 mg * Selenium 110 mg * Copper 0.9 mg * Excipients

Treatment:

Dietary Supplement: Vitamin and trace elements

Placebo dietary supplement effervescent tablet

Placebo Comparator group

Description:

Effervescent tablet with only the excipients. * Sucralose 13 mg * Sodium Chloride 20 mg * Potassium Acesulfam 22.5 mg * Orange P 55 mg * Sodium Carbonate 70 mg * Betacarotene 100 mg * Malic Acid 800 mg * Citric Acid 960 mg * Sodium bicarbonate 1,000 mg * Isomalt 1,459.50 mg

Treatment:

Dietary Supplement: Placebo