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

Study Overview
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Brief Summary
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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
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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.

Official Title
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VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity

Conditions
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COVID-19

Intervention / Treatment
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* Other: Exposure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild to severe disease<br>Mild to severe disease (admission to isolation room) | Other: Exposure<br>* Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.<br>|
| Critical patients<br>Critical patients (admission to ICU) | Other: Exposure<br>* Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity. |  | 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. |  | Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in vitamin D blood levels between COVID-19 patients in relation to mortality. |  | 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. |  | 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. |  | 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. |  | 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. |  | 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. |  | Through study completion, an average of 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Vitamin D, Vitamin D polymorphisms