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About
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-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.
Full 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.
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Inclusion criteria
Group with hydroxychloroquine treatment (HC +):
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
Primary purpose
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Interventional model
Masking
800 participants in 2 patient groups
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Central trial contact
Laurent ALRIC, Pr; Gregory PUGNET, Pr
Data sourced from clinicaltrials.gov
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