Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2022-12-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Intervention Type OTHER

COVID 19 Self-Questionnaire

Interventions

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COVID 19 serology

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

Intervention Type DIAGNOSTIC_TEST

COVID 19 Self-Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No