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Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)

Primary Purpose

Patients Infected With COVID-19

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional treatment trial for Patients Infected With COVID-19

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.

Exclusion Criteria:

Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).

Sites / Locations

Universidad de Granada
Medicine Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Intervention group

Arm Description

Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.

25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.

Outcomes

Primary Outcome Measures

Composite of cumulative death (i.e. mortality) for all causes and for specific causes.

Secondary Outcome Measures

Necessity of invasive assisted ventilation

Necessity of non-invasive assisted ventilation

Intensive care unit admission

Post-anesthesia care unit admission

Hospital admission

Medical consultation

Home care and isolation time

Bed rest time

symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19)

Subjective perception of recovery

It will be measure by questionnaire

Full Information

NCT ID

NCT04334005

First Posted

March 29, 2020

Last Updated

April 3, 2020

Sponsor

Universidad de Granada

1. Study Identification

Unique Protocol Identification Number

NCT04334005

Brief Title

Vitamin D on Prevention and Treatment of COVID-19

Acronym

COVITD-19

Official Title

Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2020 (Anticipated)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients Infected With COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.

Primary Outcome Measure Information:

Title

Composite of cumulative death (i.e. mortality) for all causes and for specific causes.

Time Frame