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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

Study Description
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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

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403932


Locations
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Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Francisco J Martín, MD PhD    618746084    fjjms@hotmail.com   
Sponsors and Collaborators
Hospital San Carlos, Madrid
More Information
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Responsible Party: Fernando Macaya, MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT04403932    
Other Study ID Numbers: 20/428-E_COVID
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Macaya, Hospital San Carlos, Madrid:
Coronavirus Disease 2019 (COVID-19)
Vitamin D Deficiency
Severe Acute Respiratory Syndrome
Angiotensin Converting Enzyme 2
Additional relevant MeSH terms:
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Coronavirus Infections
Vitamin D Deficiency
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Virus Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders