Status:
COMPLETED
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
Lead Sponsor:
University Hospital, Toulouse
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquin...
Detailed Description
A pre- or post-exposure treatment strategy has been validated in some infectious diseases. In particular, in HIV infection, this type of prophylactic treatment reduces the rate of infection in at-risk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT04481633
Start Date
September 9 2020
End Date
December 6 2022
Last Update
January 6 2026
Active Locations (12)
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1
Limoges university Hospital
Limoges, France, 87042
2
Montpellier University Hospital
Montpellier, France, 31295
3
Pitié Salpêtrière Hospital - Hépatologie
Paris, France, 75651
4
Pitié Salpêtrière Hospital - Médecine interne
Paris, France, 75651