Risk in Devel Long-COVID in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relati… (NCT06452082) | Clinical Trial Compass
CompletedNot Applicable
Risk in Devel Long-COVID in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Suppl
Italy200 participantsStarted 2024-03-20
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 vac…
What they're measuring
1
Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol.
Timeframe: to 01/01/2020 from 31/12/2022
2
Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.