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

Covid19 Clinical Trial

— CoVIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751669
• Other study ID #: CoVIT Clinical Trial
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: October 26, 2023

Study information

• Verified date: March 2024
• Source: Fundació Institut Germans Trias i Pujol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Dietary Supplement:
• Vitamin and trace elements
Dietary supplement oral route, once a day, during 14 days
• Placebo
Dietary supplement (placebo) oral route, once a day, during 14 days

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut Germans Trias i Pujol	Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for hospital admission	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
Primary	Incidence of Long Covid.	Incidence of long Covid or symptoms persistence following World Health Organization definition	6 months after beginning the study treatment
Secondary	Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid	Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)	Within day 1 at study inclusion
Secondary	Micronutrient basal status (Vitamin B12)	Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL	Within day 1 at study inclusion
Secondary	Micronutrient basal status (Iron, Zinc and Copper )	Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL	Within day 1 at study inclusion
Secondary	Micronutrient basal status (Vitamin A and Vitamin E)	Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L	Within day 1 at study inclusion
Secondary	Micronutrient basal status (Selenium )	Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L	Within day 1 at study inclusion
Secondary	Micronutrient basal status (Vitamin C)	Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL	Within day 1 at study inclusion
Secondary	Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)	Evaluation of micronutrient status in patients requiring hospitalization in ng/mL	Within the first day of hospital admission
Secondary	Micronutrient status at hospital admission ( Vitamin B12)	Evaluation of micronutrient status in patients requiring hospitalization in pg/mL	Within the first day of hospital admission
Secondary	Micronutrient status at hospital admission (Iron, Zinc and Copper)	Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL	Within the first day of hospital admission
Secondary	Micronutrient status at hospital admission (Vitamin A and Vitamin E)	Evaluation of micronutrient status in patients requiring hospitalization in mg/L	Within the first day of hospital admission
Secondary	Micronutrient status at hospital admission (Selenium)	Evaluation of micronutrient status in patients requiring hospitalization in mcg/L	Within the first day of hospital admission
Secondary	Micronutrient status at hospital admission (Vitamin C)	Evaluation of micronutrient status in patients requiring hospitalization in mg/dL	Within the first day of hospital admission
Secondary	Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)	Evaluation of micronutrient status after the study treatment in ng/mL	Within 90 days of the study treatment ending
Secondary	Micronutrient status at end of study (Vitamin B12)	Evaluation of micronutrient status after the study treatment in pg/mL	Within 90 days of the study treatment ending
Secondary	Micronutrient status at end of study (Iron, Zinc, and Copper)	Evaluation of micronutrient status after the study treatment in mcg/dL	Within 90 days of the study treatment ending
Secondary	Micronutrient status at end of study (Vitamin A and Vitamin E)	Evaluation of micronutrient status after the study treatment in mg/L	Within 90 days of the study treatment ending
Secondary	Micronutrient status at end of study (Selenium)	Evaluation of micronutrient status after the study treatment in mcg/L	Within 90 days of the study treatment ending
Secondary	Micronutrient status at end of study (Vitamin C)	Evaluation of micronutrient status after the study treatment in mg/dL	Within 90 days of the study treatment ending
Secondary	Inflammatory parameters	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
Secondary	Thromboembolic disease	Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection	From baseline to 30 days of the study treatment ending
Secondary	Oxygen supplementation	Assess the need for oxygen therapy during the clinical course of the infection	From baseline to the study follow-up period: Maximum 3 months
Secondary	High-Flow oxygen supplementation	The need for high-flow oxygen therapy during the clinical course of infection	From baseline to the study follow-up period: Maximum 3 months
Secondary	Invasive mechanical ventilation	The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented	From baseline to the study follow-up period: Maximum 3 months
Secondary	Tracheostomy	The need for tracheostomy during the clinical course of SARS-CoV-2 infection	From baseline to the study follow-up period: Maximum 3 months
Secondary	Renal replacement	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
Secondary	Death	The cumulative incidence of death from SARS-CoV-2 infection is documented	From baseline to the study follow-up period: Maximum 3 months
Secondary	Intensive Care Unit Admission	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
Secondary	Cumulative hospital admission	The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection	From baseline to the study follow-up period: Maximum 3 months
Secondary	Hospitalization needs (days)	Number of days hospitalized for a SARS-CoV-2 documented infection	From baseline to the study follow-up period: Maximum 3 months
Secondary	Survival	Survival	From baseline to the study follow-up period: Maximum 3 months
Secondary	Adverse events	Adverse events	From baseline to the study follow-up period: Maximum 3 months
Secondary	Serious Adverse Events	Serious adverse events (hospital admissions and mortality)	From baseline to the study follow-up period: Maximum 3 months
Secondary	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.	From baseline to the study follow-up period: Maximum 6 months.
Secondary	Cognitive status	Assess the Post-Covid19 cognitive status with MoCA-Blind test.	At baseline and at Day 180.
Secondary	EQ-5D	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.