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VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection (VITACOV)

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ClinicalTrials.gov Identifier: NCT04370808
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Cardiovascular Centre of Universidade de Lisboa (CCUL)
Faculty of Medicine of Universidade de Lisboa (FMUL)
Centro Hospitalar Universitário Lisboa Norte (CHULN)
Centro Hospitalar Universitário São João (CHUSJ)
CINTESIS - Center for Health Technology and Services Research
NOVA Medical School of Universidade NOVA de Lisboa
HeartGenetics, Genetics and Biotechnology SA
Instituto Gulbenkian de Ciência (IGC)
Information provided by (Responsible Party):
Fausto J. Pinto, University of Lisbon

Tracking Information
First Submitted Date April 26, 2020
First Posted Date May 1, 2020
Last Update Posted Date May 19, 2020
Estimated Study Start Date June 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2020)
  • Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity. [ Time Frame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection). ]
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity. [ Time Frame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection). ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2020)
  • Differences in vitamin D blood levels between COVID-19 patients in relation to mortality. [ Time Frame: Through study completion, an average of 3 months. ]
  • Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals. [ Time Frame: Through study completion, an average of 3 months. ]
  • Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation. [ Time Frame: Through study completion, an average of 3 months. ]
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality. [ Time Frame: Through study completion, an average of 3 months. ]
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals. [ Time Frame: Through study completion, an average of 1 year. ]
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation. [ Time Frame: Through study completion, an average of 3 months. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection
Official Title VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity
Brief Summary Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.
Detailed Description Collected data from Turin University indicate that hospitalized patients have a very high prevalence of hypovitaminosis D. Reports from China and Italy show that hypertension presents an increased risk of COVID-19-related death. Otherwise, observational studies suggest that 25(OH)D induces protection against respiratory pathogens while large-scale studies indicate that serum 25(OH)D-level is inversely correlated to hypertension prevalence. Recent published data (2020) shows that 66% of Portuguese adults present Vitamin D deficiency. HeartGenetics' genetic database with more than 8.500 Portuguese genotypes shows that the prevalence of vitamin D polymorphisms in this population is 4-fold higher than the EU average, increasing the risk of hypovitaminosis D.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population COVID-19 patients admitted to hospitals from Lisbon and Oporto.
Condition COVID-19
Intervention Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
Study Groups/Cohorts
  • Mild to severe disease
    Mild to severe disease (admission to isolation room)
    Intervention: Other: Exposure
  • Critical patients
    Critical patients (admission to ICU)
    Intervention: Other: Exposure
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 Not yet recruiting
Estimated Enrollment
 (submitted: April 29, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults of 18 years and above.
  • COVID-19 patients admitted with mild to severe disease (admission to isolation room) or critical patients (admission to ICU).
  • Available to comply with study protocol and sign informed consent.

Exclusion Criteria:

  • Patients diagnosed with COVID-19 not admitted to hospital.
  • Patients unable to provide informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fausto J Pinto, PhD 00351217985113 faustopinto@medicina.ulisboa.pt
Contact: Conceição Calhau, PhD 00351218803035 ext 20401 ccalhau@nms.unl.pt
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT04370808
Other Study ID Numbers VITACOV
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
Plan to Share IPD: Undecided
Responsible Party Fausto J. Pinto, University of Lisbon
Study Sponsor University of Lisbon
Collaborators
  • Cardiovascular Centre of Universidade de Lisboa (CCUL)
  • Faculty of Medicine of Universidade de Lisboa (FMUL)
  • Centro Hospitalar Universitário Lisboa Norte (CHULN)
  • Centro Hospitalar Universitário São João (CHUSJ)
  • CINTESIS - Center for Health Technology and Services Research
  • NOVA Medical School of Universidade NOVA de Lisboa
  • HeartGenetics, Genetics and Biotechnology SA
  • Instituto Gulbenkian de Ciência (IGC)
Investigators
Principal Investigator: Fausto J Pinto, PhD Faculty of Medicine of Universidade de Lisboa
Principal Investigator: Conceição Calhau, PhD NOVA Medical School of Universidade NOVA de Lisboa
Principal Investigator: Ana Freitas, PhD HeartGenetics SA
Principal Investigator: Tiago Guimarães, PhD Faculty of Medicine of the University of Porto
PRS Account University of Lisbon
Verification Date May 2020