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

NCT ID: NCT04403932

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-17

Study Completion Date

2020-08-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Coronavirus Disease 2019 (COVID-19)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Fernando Macaya

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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20/428-E_COVID

Identifier Type: -

Identifier Source: org_study_id

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