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