CoVIT: Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial
Study Details
Study Description
Brief Summary
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 90 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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Type of study/ Design: Randomized, double-blind, placebo-controlled clinical trial.
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Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
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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.
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Protocol code: CoVIT Clinical Trial
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NºClinicaltrials.gov: Pending
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Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
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Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
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Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
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Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
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Study treatments: Dietary supplement with micronutrients and Placebo
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Test phase: Not applicable.
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Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection.
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Study pathology: COVID-19.
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Main variable: The need for hospital admission of SARS-CoV-2 documented infection
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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).
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Duration of treatment: 14 days.
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Patients follow-up: 90 days
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Micronutrient dietary supplement effervescent tablet 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 |
Dietary Supplement: Vitamin and trace elements
Dietary supplement oral route, once a day, during 14 days
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| Placebo Comparator: Placebo dietary supplement effervescent tablet 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 |
Dietary Supplement: Placebo
Dietary supplement (placebo) oral route, once a day, during 14 days
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Outcome Measures
Primary Outcome Measures
- Need for hospital admission [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
Secondary Outcome Measures
- Micronutrient basal status (Vitamin A, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin C, 25-OH-Vitamin D,Vitamin E, Folic Acid, Iron, Zinc, Copper, Selenium ) [Within day 1 at study inclusion]
Evaluation of micronutrient status prior to the nutritional supplement administration
- Micronutrient status at hospital admission (Vitamin A, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin C, 25-OH-Vitamin D,Vitamin E, Folic Acid, Iron, Zinc, Copper, Selenium) [Within the first day of hospital admission]
Evaluation of micronutrient status in patients requiring hospitalization
- Micronutrient status at end of study (Vitamin A, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin C, 25-OH-Vitamin D,Vitamin E, Folic Acid, Iron, Zinc, Copper, Selenium) [Within 90 days of the study treatment ending]
Evaluation of micronutrient status after the study treatment
- Inflammatory parameters [From baseline to 30 days of the study treatment ending]
Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients
- Thromboembolic disease [From baseline to 30 days of the study treatment ending]
Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection
- Oxygen supplementation [From baseline to the study follow-up period: Maximum 3 months]
Assess the need for oxygen therapy during the clinical course of the infection
- High-Flow oxygen supplementation [From baseline to the study follow-up period: Maximum 3 months]
The need for high-flow oxygen therapy during the clinical course of infection
- Invasive mechanical ventilation [From baseline to the study follow-up period: Maximum 3 months]
The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented
- Tracheostomy [From baseline to the study follow-up period: Maximum 3 months]
The need for tracheostomy during the clinical course of SARS-CoV-2 infection
- Renal replacement [From baseline to the study follow-up period: Maximum 3 months]
The need for renal replacement therapies during the clinical course of SARS-CoV-2 infection
- Death [From baseline to the study follow-up period: Maximum 3 months]
The cumulative incidence of death from SARS-CoV-2 infection is documented
- Intensive Care Unit Admission [From baseline to the study follow-up period: Maximum 3 months]
The cumulative incidence of admission to intensive care for SARS-CoV-2 infection documented
- Cumulative hospital admission [From baseline to the study follow-up period: Maximum 3 months]
The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection
- Hospitalization needs (days) [From baseline to the study follow-up period: Maximum 3 months]
Number of days hospitalized for a SARS-CoV-2 documented infection
- Survival [From baseline to the study follow-up period: Maximum 3 months]
Survival
- Adverse events [From baseline to the study follow-up period: Maximum 3 months]
Adverse events
- Serious Adverse Events [From baseline to the study follow-up period: Maximum 3 months]
Serious adverse events (hospital admissions and mortality)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed Consent Form signed.
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Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
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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.
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Age ≥ 65 years.
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Age ≥ 45 years with 1 or more comorbidities (diabetes, hypertension, obesity, heart disease, respiratory disease).
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Availability to meet the requirements of the protocol.
Exclusion Criteria:
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Intake of any micronutrient supplement during the month prior to inclusion.
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Patients fulfilling hospitalization criteria.
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Previous allergies to the micronutrient components and excipients.
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SARS-CoV-2 completed vaccination (2 doses)
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Age ≥ 80 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
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Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
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Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
Sponsors and Collaborators
- Fundació Institut Germans Trias i Pujol
- Germans Trias i Pujol Hospital
Investigators
- Principal Investigator: Teresa M Tomasa-Irriguible, MD-PhD, Hospital Germans Trias i Pujol- Intensive Care Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoVIT Clinical Trial