Clinical trial NCT04751669: Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial
Official title: Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Dietary Supplement
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2021-02-12
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo-controlled, randomized clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Need for hospital admission
timeFrame: From baseline to 1 month after beginning the study treatment
measure: Incidence of Long Covid.
timeFrame: 6 months after beginning the study treatment
Secondary outcomes:
measure: Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid
timeFrame: Within day 1 at study inclusion
measure: Micronutrient basal status (Vitamin B12)
timeFrame: Within day 1 at study inclusion
measure: Micronutrient basal status (Iron, Zinc and Copper )
timeFrame: Within day 1 at study inclusion
measure: Micronutrient basal status (Vitamin A and Vitamin E)
timeFrame: Within day 1 at study inclusion
measure: Micronutrient basal status (Selenium )
timeFrame: Within day 1 at study inclusion
measure: Micronutrient basal status (Vitamin C)
timeFrame: Within day 1 at study inclusion
measure: Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at hospital admission ( Vitamin B12)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at hospital admission (Iron, Zinc and Copper)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at hospital admission (Vitamin A and Vitamin E)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at hospital admission (Selenium)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at hospital admission (Vitamin C)
timeFrame: Within the first day of hospital admission
measure: Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
timeFrame: Within 90 days of the study treatment ending
measure: Micronutrient status at end of study (Vitamin B12)
timeFrame: Within 90 days of the study treatment ending
measure: Micronutrient status at end of study (Iron, Zinc, and Copper)
timeFrame: Within 90 days of the study treatment ending
measure: Micronutrient status at end of study (Vitamin A and Vitamin E)
timeFrame: Within 90 days of the study treatment ending
measure: Micronutrient status at end of study (Selenium)
timeFrame: Within 90 days of the study treatment ending
measure: Micronutrient status at end of study (Vitamin C)
timeFrame: Within 90 days of the study treatment ending
measure: Inflammatory parameters
timeFrame: From baseline to 30 days of the study treatment ending
measure: Thromboembolic disease
timeFrame: From baseline to 30 days of the study treatment ending
measure: Oxygen supplementation
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: High-Flow oxygen supplementation
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Invasive mechanical ventilation
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Tracheostomy
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Renal replacement
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Death
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Intensive Care Unit Admission
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Cumulative hospital admission
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Hospitalization needs (days)
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Survival
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Adverse events
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Serious Adverse Events
timeFrame: From baseline to the study follow-up period: Maximum 3 months
measure: Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).
timeFrame: From baseline to the study follow-up period: Maximum 6 months.
measure: Cognitive status
timeFrame: At baseline and at Day 180.
measure: EQ-5D
timeFrame: At baseline and at Day 180.
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Hospital Germans Trias i Pujol- Intensive Care Unit
name: Teresa M Tomasa-Irriguible, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.