Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Fundació Institut Germans Trias i Pujol
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Need for hospital admission
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent Form signed.
- •Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
- •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.
- •Age ≥ 18 years
- •Availability to meet the requirements of the protocol.
Exclusion Criteria
- •Intake of any micronutrient supplement during the month prior to inclusion.
- •Patients fulfilling hospitalization criteria.
- •Previous allergies to the micronutrient components and excipients.
- •Age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
- •Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
- •Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
- •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
- •Pregnancy or breastfeeding
Outcomes
Primary Outcomes
Need for hospital admission
Time Frame: From baseline to 1 month after beginning the study treatment
The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease
Incidence of Long Covid.
Time Frame: 6 months after beginning the study treatment
Incidence of long Covid or symptoms persistence following World Health Organization definition
Secondary Outcomes
- Micronutrient basal status (Vitamin B12)(Within day 1 at study inclusion)
- Micronutrient basal status (Vitamin A and Vitamin E)(Within day 1 at study inclusion)
- Micronutrient status at hospital admission (Iron, Zinc and Copper)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Vitamin C)(Within the first day of hospital admission)
- Micronutrient basal status (Iron, Zinc and Copper )(Within day 1 at study inclusion)
- Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid(Within day 1 at study inclusion)
- Micronutrient status at end of study (Vitamin A and Vitamin E)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Selenium)(Within 90 days of the study treatment ending)
- Thromboembolic disease(From baseline to 30 days of the study treatment ending)
- Death(From baseline to the study follow-up period: Maximum 3 months)
- Intensive Care Unit Admission(From baseline to the study follow-up period: Maximum 3 months)
- Hospitalization needs (days)(From baseline to the study follow-up period: Maximum 3 months)
- Adverse events(From baseline to the study follow-up period: Maximum 3 months)
- Micronutrient basal status (Selenium )(Within day 1 at study inclusion)
- Micronutrient status at hospital admission ( Vitamin B12)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Selenium)(Within the first day of hospital admission)
- Micronutrient status at end of study (Vitamin B12)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Iron, Zinc, and Copper)(Within 90 days of the study treatment ending)
- High-Flow oxygen supplementation(From baseline to the study follow-up period: Maximum 3 months)
- Invasive mechanical ventilation(From baseline to the study follow-up period: Maximum 3 months)
- Cumulative hospital admission(From baseline to the study follow-up period: Maximum 3 months)
- Survival(From baseline to the study follow-up period: Maximum 3 months)
- Serious Adverse Events(From baseline to the study follow-up period: Maximum 3 months)
- Cognitive status(At baseline and at Day 180.)
- Micronutrient basal status (Vitamin C)(Within day 1 at study inclusion)
- Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Vitamin A and Vitamin E)(Within the first day of hospital admission)
- Oxygen supplementation(From baseline to the study follow-up period: Maximum 3 months)
- Tracheostomy(From baseline to the study follow-up period: Maximum 3 months)
- Renal replacement(From baseline to the study follow-up period: Maximum 3 months)
- Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Vitamin C)(Within 90 days of the study treatment ending)
- Inflammatory parameters(From baseline to 30 days of the study treatment ending)
- Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).(From baseline to the study follow-up period: Maximum 6 months.)
- EQ-5D(At baseline and at Day 180.)