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

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ClinicalTrials.gov Identifier: NCT04403932
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : June 1, 2020
Sponsor:
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 June 1, 2020
Actual Study Start Date April 17, 2020
Estimated 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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 26, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2020
Estimated 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
Listed Location Countries Spain
Removed Location Countries  
 
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 May 2020