Clinical trial NCT04370808: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Vitamin D
Vitamin D polymorphisms
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Cardiovascular Centre of Universidade de Lisboa (CCUL)
name: Faculty of Medicine of Universidade de Lisboa (FMUL)
name: Centro Hospitalar Universitário Lisboa Norte
name: Centro Hospitalar Universitário São João (CHUSJ)
name: CINTESIS - Center for Health Technology and Services Research
name: Universidade Nova de Lisboa
name: HeartGenetics, Genetics and Biotechnology SA
name: Instituto Gulbenkian de Ciência (IGC)
First posted: 2020-05-01
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients admitted to hospitals from Lisbon and Oporto.

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.

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.

Primary outcomes:
measure: Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.
timeFrame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.
timeFrame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
Secondary outcomes:
measure: Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.
timeFrame: Through study completion, an average of 3 months.
measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.
timeFrame: Through study completion, an average of 1 year.
measure: Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.
timeFrame: Through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Cardiovascular Center at Universidade de Lisboa
state: Lisboa
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte
state: Lisboa
city: Oporto
country: Portugal
facility: Centro Hospitalar de São João
Study officials:
affiliation: Faculty of Medicine of Universidade de Lisboa
name: Fausto J Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Nova de Lisboa
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HeartGenetics SA
name: Ana Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine of the University of Porto
name: Tiago Guimarães, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BioData.pt/Instituto Gulbenkian Ciência
name: Ana Melo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freitas AT, Calhau C, Antunes G, Araujo B, Bandeira M, Barreira S, Bazenga F, Braz S, Caldeira D, Santos SCR, Faria A, Faria D, Fraga M, Nogueira-Garcia B, Goncalves L, Kovalchuk P, Lacerda L, Lopes H, Luis D, Medeiros F, Melo AMP, Melo-Cristino J, Miranda A, Pereira C, Pinto AT, Pinto J, Proenca H, Ramos A, Rato JPR, Rocha F, Rocha JC, Moreira-Rosario A, Vazao H, Volovetska Y, Guimaraes JT, Pinto FJ. Vitamin D-related polymorphisms and vitamin D levels as risk biomarkers of COVID-19 disease severity. Sci Rep. 2021 Oct 21;11(1):20837. doi: 10.1038/s41598-021-99952-z.