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Clinical Trials/NCT04403932
NCT04403932
Completed
Not Applicable

Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)

Hospital San Carlos, Madrid1 site in 1 country300 target enrollmentApril 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus Disease 2019 (COVID-19)
Sponsor
Hospital San Carlos, Madrid
Enrollment
300
Locations
1
Primary Endpoint
severe COVID-19
Status
Completed
Last Updated
5 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2020
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernando Macaya

MD

Hospital San Carlos, Madrid

Eligibility Criteria

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

Outcomes

Primary Outcomes

severe COVID-19

Time Frame: 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

Study Sites (1)

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