Official Title
Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease
Brief Summary

There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.

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 populations. The first studies from Chinese show that in
case of immunosuppression or immunosuppressive treatment, whatever the causal pathology,
COVID-19 infection is more severe. The present study presents a population of patients
with lupus (SLE) or Gougerot's disease (SGD) who are treated for a long time, with
Hydroxy-Chloroquine. The protective effect against COVID-19 infection of
Hydroxy-Chloroquine compared to populations not exposed to this drug requires to be
assessed in patients and their control groups under or without immunosuppressive
treatments.

It is hypothesized that long-term treatment with Hydroxy-Chloroquine in SLE or SGD taken
in its usual indication before the onset of the pandemic could decrease the number of
COVID19 infections and/or the intensity of the disease.

Unknown status
COVID-19

Diagnostic Test: COVID 19 serology

Diagnosis of Covid-19 past infection will be made by serology

Other: COVID 19 Self-Questionnaire

COVID 19 Self-Questionnaire

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Limoges university Hospital
Limoges, France

Montpellier University Hospital
Montpellier, France

Pitié Salpêtrière Hospital - Hépatologie
Paris, France

Pitié Salpêtrière Hospital - Médecine interne
Paris, France

Haut-Lévêque Hospital - Gastro-entérologie
Pessac, France

Haut-Lévêque Hospital - Médecine interne
Pessac, France

Joseph Ducuing Hospital - Médecine interne
Toulouse, France

Toulouse university Hospital - Larrey Dermatologie
Toulouse, France

Toulouse University Hospital - Rhumatologie
Toulouse, France

Toulouse University Hospital
Toulouse, France

University Hospital of Toulouse - Rangueil Médecine interne
Toulouse, France

University hospital Toulouse - Purpan Médecine interne
Toulouse, France

Contacts

Laurent ALRIC, Pr
05 61 32 29 09 - +33
alric.l@chu-toulouse.fr

Gregory PUGNET, Pr
(0)5 61 77 71 26 - +33
pugnet.g@chu-toulouse.fr

Laurent ALRIC, Pr, Principal Investigator
University Hospital, Toulouse

University Hospital, Toulouse
NCT Number
Keywords
lupus erythematous disease
prophylaxis
pre-emptive therapy
Hydroxy-Chloroquine
MeSH Terms
COVID-19