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

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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019 (COVID-19)

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive adult subjects attending the emergency department with symptoms suggestive of COVID-19 and a positive reverse-transcriptase polymerase chain reaction for SARS-CoV-2

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe COVID-19	death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula	17/04/2020 to 01/06/2020

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D Deficiency; Severe Acute Respiratory Syndrome; Coronavirus Disease 2019 (COVID-19); Angiotensin Converting Enzyme 2
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; COVID-19; Coronavirus Infections; Vitamin D Deficiency
• Other Study ID Numbers: 20/428-E_COVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No