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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 23
- 主要终点
- Number of Participants With Positive Anti-SARS-CoV-2 Serology
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Patients treated with immunosuppressants for at least three months before the start of the pandemic at COVID 19, at least since December
- •COVID19 diagnostic questionnaire and available serology result.
排除标准
- •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-
- •Protected adults
- •Pregnant or breastfeeding women.
- •Lack of health insurance coverage
研究组 & 干预措施
Patient treated with Hydroxy-chloroquine
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
干预措施: COVID 19 serology (Diagnostic Test)
Patient treated with Hydroxy-chloroquine
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
干预措施: COVID 19 Self-Questionnaire (Other)
Patient without treatment with Hydroxy-chloroquine
patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
干预措施: COVID 19 serology (Diagnostic Test)
Patient without treatment with Hydroxy-chloroquine
patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
干预措施: COVID 19 Self-Questionnaire (Other)
结局指标
主要结局
Number of Participants With Positive Anti-SARS-CoV-2 Serology
时间窗: 12 months post inclusion
Number of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine
次要结局
- Number of Patients Who Experienced Symptomatic or Severe (Hospitalization) COVID-19 Infection(From inclusion until the end of the study (at M12))