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COVIT-D: Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT04403932
Collaborator
(none)
300
Enrollment
1
Location
3.5
Actual Duration (Months)
86.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)
    Actual Study Start Date :
    Apr 17, 2020
    Actual Primary Completion Date :
    Jun 1, 2020
    Actual Study Completion Date :
    Aug 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. severe COVID-19 [17/04/2020 to 01/06/2020]

      death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years old

    • symptoms suggestive of COVID-19

    • positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2

    Exclusion Criteria:
    • Bacterial community acquired pneumonia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico San Carlos Madrid Spain 28040

    Sponsors and Collaborators

    • Hospital San Carlos, Madrid

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernando Macaya, MD, Hospital San Carlos, Madrid
    ClinicalTrials.gov Identifier:
    NCT04403932
    Other Study ID Numbers:
    • 20/428-E_COVID
    First Posted:
    May 27, 2020
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fernando Macaya, MD, Hospital San Carlos, Madrid
    Coronavirus Disease 2019 (COVID-19)
    Vitamin D Deficiency
    Severe Acute Respiratory Syndrome
    Angiotensin Converting Enzyme 2
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Feb 1, 2021