COVID-19 Clinical Trial
— LONGVITAVAX2Official title:
Retrospective Observational Study on the Risk in Developing Long-COVID Syndrome After Acute COVID-19 Disease and in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Supplementation in Outpatients of Endocrinology Department
Verified date | June 2024 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this observational retrospective study is to evaluate the effect of supplementation with cholecalciferol D3 in reducing the risk of: - occurence of Long COVID syndrome after acute COVID-19 illness - occurence of SARS-CoV-2 infection after anti-COVID-19 vaccination
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | March 2027 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (For aim I): - age =18 - outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022 - previous SARS CoV-2 infection - clinical,anamnestic and therapeutic data 6 months post SARS CoV-2 infection - data on cholecalciferol supplementation - signature of informed consent Exclusion Criteria (For aim I): - age = 18 - pregnant or breastfeeding women - patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions - patients treated with drugs that interfere with vitamin D metabolism - first vaccination anti Sars COVID performed before the acute infection - first vaccination performed within 6 months of the acute infection - patients unable to sign the informed consent Inclusion Criteria (For aim 2) -- age =18 - outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022 - vaccination with BNT162b2 Biontec mRNA Pfizer/BioNtech - clinical, anamnestic and therapeutic data 6 months post SARS CoV-2 infection - data on cholecalciferol supplementation - signature of informed consent Exclusion Criteria (For aim 2): - age = 18 - pregnant or breastfeeding women - patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions - patients treated with drugs that interfere with vitamin D metabolism - additional vaccination performed before 6-12 months - acute infection before the vaccination - patients unable to sign the informed consent |
Country | Name | City | State |
---|---|---|---|
Italy | Luigi di Filippo | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol. | Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in outpatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022 | to 01/01/2020 from 31/12/2022 | |
Primary | Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol. | Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in oupatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022 | to 01/01/2020 from 31/12/2022 |
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