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Completed

NCT Number: NCT04751669

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin and trace elements

Dietary Supplement

Dietary supplement oral route, once a day, during 14 days

Placebo

Dietary Supplement

Dietary supplement (placebo) oral route, once a day, during 14 days

Primary outcomes

  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

  2. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. Survival

    Time frame: From baseline to the study follow-up period: Maximum 3 months

    Survival

  31. Adverse events

    Time frame: From baseline to the study follow-up period: Maximum 3 months

    Adverse events

  32. Serious Adverse Events

    Time frame: From baseline to the study follow-up period: Maximum 3 months

    Serious adverse events (hospital admissions and mortality)

  33. 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.

  34. Cognitive status

    Time frame: At baseline and at Day 180.

    Assess the Post-Covid19 cognitive status with MoCA-Blind test.

  35. 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

Sponsors and collaborators

Lead sponsor

Fundació Institut Germans Trias i Pujol

Other

Collaborators

  • Germans Trias i Pujol Hospital

Registry information

Official study title

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

Acronym: CoVIT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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