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

March 22, 2024 updated by: Fundació Institut Germans Trias i Pujol

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 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline to 1 month after beginning the study treatment
Incidence of Long Covid.
Time Frame: 6 months after beginning the study treatment
Incidence of long Covid or symptoms persistence following World Health Organization definition
6 months after beginning the study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
From baseline to 30 days of the study treatment ending
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
From baseline to 30 days of the study treatment ending
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
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
From baseline to the study follow-up period: Maximum 3 months
Survival
Time Frame: From baseline to the study follow-up period: Maximum 3 months
Survival
From baseline to the study follow-up period: Maximum 3 months
Adverse events
Time Frame: From baseline to the study follow-up period: Maximum 3 months
Adverse events
From baseline to the study follow-up period: Maximum 3 months
Serious Adverse Events
Time Frame: From baseline to the study follow-up period: Maximum 3 months
Serious adverse events (hospital admissions and mortality)
From baseline to the study follow-up period: Maximum 3 months
Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)
Within day 1 at study inclusion
Micronutrient basal status (Vitamin B12)
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL
Within day 1 at study inclusion
Micronutrient basal status (Iron, Zinc and Copper )
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL
Within day 1 at study inclusion
Micronutrient basal status (Vitamin A and Vitamin E)
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L
Within day 1 at study inclusion
Micronutrient basal status (Selenium )
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L
Within day 1 at study inclusion
Micronutrient basal status (Vitamin C)
Time Frame: Within day 1 at study inclusion
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL
Within day 1 at study inclusion
Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in ng/mL
Within the first day of hospital admission
Micronutrient status at hospital admission ( Vitamin B12)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in pg/mL
Within the first day of hospital admission
Micronutrient status at hospital admission (Iron, Zinc and Copper)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL
Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin A and Vitamin E)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in mg/L
Within the first day of hospital admission
Micronutrient status at hospital admission (Selenium)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in mcg/L
Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin C)
Time Frame: Within the first day of hospital admission
Evaluation of micronutrient status in patients requiring hospitalization in mg/dL
Within the first day of hospital admission
Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in ng/mL
Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin B12)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in pg/mL
Within 90 days of the study treatment ending
Micronutrient status at end of study (Iron, Zinc, and Copper)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in mcg/dL
Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin A and Vitamin E)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in mg/L
Within 90 days of the study treatment ending
Micronutrient status at end of study (Selenium)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in mcg/L
Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin C)
Time Frame: Within 90 days of the study treatment ending
Evaluation of micronutrient status after the study treatment in mg/dL
Within 90 days of the study treatment ending
Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).
Time Frame: From baseline to the study follow-up period: Maximum 6 months.

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.
From baseline to the study follow-up period: Maximum 6 months.
Cognitive status
Time Frame: At baseline and at Day 180.
Assess the Post-Covid19 cognitive status with MoCA-Blind test.
At baseline and at Day 180.
EQ-5D
Time Frame: At baseline and at Day 180.

Assess the evolution of quality of life during the study.

EQ-5D-5L quality of life questionnaire will be administered
At baseline and at Day 180.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut Germans Trias i Pujol

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Germans Trias i Pujol Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa M Tomasa-Irriguible, MD-PhD, Hospital Germans Trias i Pujol- Intensive Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CoVIT Clinical Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Dietary Supplements

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