Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04481633
Eligibility Criteria:
Inclusion Criteria:
Group with hydroxychloroquine treatment (HC +):
* LED/SG diagnosed
* Treatment with Hydroxy-Chloroquine in the 3 months before and during the outbreak at COVID 19, at least in December 2019. Patients may have treatment with immunosuppressants in combination with Hydroxy-Chloroquine.
* COVID19 diagnostic questionnaire and available serology result.
Group without hydroxychloroquine treatment (HC-) :
* No Hydroxy-Chloroquine intake for more than 12 months
--\> HC- without an immunosuppressant
* Viral hepatitis C cured for more than 12 months or primitive bile cholangitis (CBP) whose diagnosis is based on international criteria.
* Non-significant liver fibrosis assessed either by historical histology or by fibroscan with non-significant liver fibrosis Metavir - F3 (at last available examination)
* No Hydroxy-Chloroquine, or immunosuppressants have been taken for more than 12 months.
* COVID19 diagnostic questionnaire and COVID19 serology result available.
--\>HC- with an immunosuppressant
* Diagnosis of LED/SG according to the CAB criteria revised in 1997 or autoimmune hepatitis according to the international criteria validated in 2008.
* Patients treated with immunosuppressants for at least three months before the start of the pandemic at COVID 19, at least since December 2019.
* COVID19 diagnostic questionnaire and available serology result.
Exclusion Criteria:
* Anti-CD20 or Cyclophosphamide taken during the six months prior to the completion of the COVID 19 serology.
* Refusal of a blood test for antibodies to COVID-19.
* Protected adults
* Pregnant or breastfeeding women.
* Lack of health insurance coverage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04481633
Study Brief:
Protocol Section:
NCT04481633