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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04751669
Recruitment Status : Not yet recruiting
First Posted : February 12, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
Fundació Institut Germans Trias i Pujol

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
Covid19 Dietary Supplement: Vitamin and trace elements Dietary Supplement: Placebo Not Applicable

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: 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: 90 days

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, placebo-controlled, randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo tablets with the same external aspect than the dietary supplement, the same administration route, containing only the excipients
Primary Purpose: Treatment
Official Title: Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ) [ Time Frame: Within day 1 at study inclusion ]
    Evaluation of micronutrient status prior to the nutritional supplement administration

  2. 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) [ Time Frame: Within the first day of hospital admission ]
    Evaluation of micronutrient status in patients requiring hospitalization

  3. 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) [ Time Frame: Within 90 days of the study treatment ending ]
    Evaluation of micronutrient status after the study treatment

  4. Inflammatory parameters [ Time Frame: 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

  5. Thromboembolic disease [ Time Frame: From baseline to 30 days of the study treatment ending ]
    Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection

  6. Oxygen supplementation [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    Assess the need for oxygen therapy during the clinical course of the infection

  7. High-Flow oxygen supplementation [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    The need for high-flow oxygen therapy during the clinical course of infection

  8. Invasive mechanical ventilation [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented

  9. Tracheostomy [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    The need for tracheostomy during the clinical course of SARS-CoV-2 infection

  10. Renal replacement [ Time Frame: 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

  11. Death [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    The cumulative incidence of death from SARS-CoV-2 infection is documented

  12. Intensive Care Unit Admission [ Time Frame: 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

  13. Cumulative hospital admission [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection

  14. Hospitalization needs (days) [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    Number of days hospitalized for a SARS-CoV-2 documented infection

  15. Survival [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    Survival

  16. Adverse events [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    Adverse events

  17. Serious Adverse Events [ Time Frame: From baseline to the study follow-up period: Maximum 3 months ]
    Serious adverse events (hospital admissions and mortality)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 65 years.
  5. Age ≥ 45 years with 1 or more comorbidities (diabetes, hypertension, obesity, heart disease, respiratory disease).
  6. 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. SARS-CoV-2 completed vaccination (2 doses)
  5. Age ≥ 80 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
  6. Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
  7. Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751669


Contacts
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Contact: Teresa M Tomasa-Irriguible, MD-PhD +34934978901 ttomasa.germanstrias@gencat.cat
Contact: Ana M Barriocanal, MD-PhD +34934978488 ambarriocanal@igtp.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Contact: Teresa M Tomasa-Irriguible, MD-PhD    +34934978901    ttomasa.germanstrias@gencat.cat   
Contact: Ana M Barriocanal, MD-PhD    +34934978488    ambarriocanal@igtp.cat   
Sub-Investigator: Eva Martínez-Cáceres, MD.PhD         
Sub-Investigator: Rosa Morros, MD.PhD         
Sub-Investigator: Ana M Barriocanal, MD.PhD         
Sub-Investigator: Luisa Bordejé-Laguna, MD         
Sub-Investigator: Jaume Barallat, PhD         
Sub-Investigator: Gema Fernández, MD.PhD         
Sub-Investigator: Neus Robert Boter, MD.         
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Teresa M Tomasa-Irriguible, MD-PhD Hospital Germans Trias i Pujol- Intensive Care Unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT04751669    
Other Study ID Numbers: CoVIT Clinical Trial
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut Germans Trias i Pujol:
Dietary Supplement
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Trace Elements
Micronutrients
Physiological Effects of Drugs