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

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

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

A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19. 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.

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: 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. Study pathology: COVID-19. Main variable: The need for hospital admission of SARS-CoV-2 documented infection 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

Placebo tablets with the same external aspect than the dietary supplement, the same administration route, containing only the excipients

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

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

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

Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients

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.

Assess the evolution of quality of life during the study. EQ-5D-5L quality of life questionnaire will be administered

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

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.