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
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
Dietary supplement oral route, once a day, during 14 days
Dietary supplement (placebo) oral route, once a day, during 14 days
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Need for hospital admission
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
Time frame: From baseline to 1 month after beginning the study treatment
Incidence of Long Covid.
Incidence of long Covid or symptoms persistence following World Health Organization definition
Time frame: 6 months after beginning the study treatment
Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid
Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin B12)
Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Iron, Zinc and Copper )
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin A and Vitamin E)
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Selenium )
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin C)
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL
Time frame: Within day 1 at study inclusion
Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Evaluation of micronutrient status in patients requiring hospitalization in ng/mL
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission ( Vitamin B12)
Evaluation of micronutrient status in patients requiring hospitalization in pg/mL
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Iron, Zinc and Copper)
Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin A and Vitamin E)
Evaluation of micronutrient status in patients requiring hospitalization in mg/L
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Selenium)
Evaluation of micronutrient status in patients requiring hospitalization in mcg/L
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin C)
Evaluation of micronutrient status in patients requiring hospitalization in mg/dL
Time frame: Within the first day of hospital admission
Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Evaluation of micronutrient status after the study treatment in ng/mL
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin B12)
Evaluation of micronutrient status after the study treatment in pg/mL
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Iron, Zinc, and Copper)
Evaluation of micronutrient status after the study treatment in mcg/dL
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin A and Vitamin E)
Evaluation of micronutrient status after the study treatment in mg/L
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Selenium)
Evaluation of micronutrient status after the study treatment in mcg/L
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin C)
Evaluation of micronutrient status after the study treatment in mg/dL
Time frame: Within 90 days of the study treatment ending
Inflammatory parameters
Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients
Time frame: From baseline to 30 days of the study treatment ending
Thromboembolic disease
Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection
Time frame: From baseline to 30 days of the study treatment ending
Oxygen supplementation
Assess the need for oxygen therapy during the clinical course of the infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
High-Flow oxygen supplementation
The need for high-flow oxygen therapy during the clinical course of infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
Invasive mechanical ventilation
The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented
Time frame: From baseline to the study follow-up period: Maximum 3 months
Tracheostomy
The need for tracheostomy during the clinical course of SARS-CoV-2 infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
Renal replacement
The need for renal replacement therapies during the clinical course of SARS-CoV-2 infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
Death
The cumulative incidence of death from SARS-CoV-2 infection is documented
Time frame: From baseline to the study follow-up period: Maximum 3 months
Intensive Care Unit Admission
The cumulative incidence of admission to intensive care for SARS-CoV-2 infection documented
Time frame: From baseline to the study follow-up period: Maximum 3 months
Cumulative hospital admission
The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
Hospitalization needs (days)
Number of days hospitalized for a SARS-CoV-2 documented infection
Time frame: From baseline to the study follow-up period: Maximum 3 months
Survival
Survival
Time frame: From baseline to the study follow-up period: Maximum 3 months
Adverse events
Adverse events
Time frame: From baseline to the study follow-up period: Maximum 3 months
Serious Adverse Events
Serious adverse events (hospital admissions and mortality)
Time frame: From baseline to the study follow-up period: Maximum 3 months
Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).
Assess the Post-Covid19 Persistent Symptoms, directly asking patient for Symptoms at the moment of an On site visit at Day 90 and at thelephonic contact on Day 180. Questionnaire to the patient to asess persistent symptoms on the following areas: Neurologic: Montreal Cognitive Assessment (Mo-CA-BLIND) and Persistent cefalea Psicologic: Anxiety, depression, sleep and mood transtorns Digestive: dispepsia, diarrea, constipation Cardiovascular: tachicardia, arrhythmia, acute mycardial infarction and Ictus Respiratory: dispnea, chest pain Osteomuscular: astenia, artralgia and myalgia and other symptoms expressed by the patient.
Time frame: From baseline to the study follow-up period: Maximum 6 months.
Cognitive status
Assess the Post-Covid19 cognitive status with MoCA-Blind test.
Time frame: At baseline and at Day 180.
EQ-5D
Assess the evolution of quality of life during the study. EQ-5D-5L quality of life questionnaire will be administered
Time frame: At baseline and at Day 180.
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