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

• ClinicalTrials.gov Identifier: NCT04403932
• Recruitment Status: Completed
• First Posted: May 27, 2020
• Last Update Posted: February 1, 2021
• Sponsor: Hospital San Carlos, Madrid
• Information provided by (Responsible Party): Fernando Macaya, Hospital San Carlos, Madrid

Tracking Information

• First Submitted Date: May 24, 2020
• First Posted Date: May 27, 2020
• Last Update Posted Date: February 1, 2021
• Actual Study Start Date: April 17, 2020
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 26, 2020)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency
• 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)
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Coronavirus Disease 2019 (COVID-19)
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2021): 300
• Original Estimated Enrollment (submitted: May 26, 2020): 500
• Actual Study Completion Date: August 1, 2020
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04403932
• Other Study ID Numbers: 20/428-E_COVID
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Fernando Macaya, Hospital San Carlos, Madrid
• Study Sponsor: Hospital San Carlos, Madrid
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital San Carlos, Madrid
• Verification Date: January 2021