Clinical trial NCT04481633: Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: lupus erythematous disease
prophylaxis
pre-emptive therapy
Hydroxy-Chloroquine
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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-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.

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.

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

Primary outcomes:
measure: Rate of patients with positive anti-COVID19 serology
timeFrame: Day 1
Secondary outcomes:
measure: Rate of patients with symptomatic or severe (hospitalization) form of infection
timeFrame: Day 1
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges university Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Paris
country: France
facility: Pitié Salpêtrière Hospital - Hépatologie
city: Paris
country: France
facility: Pitié Salpêtrière Hospital - Médecine interne
city: Pessac
country: France
facility: Haut-Lévêque Hospital - Gastro-entérologie
city: Pessac
country: France
facility: Haut-Lévêque Hospital - Médecine interne
city: Toulouse
country: France
facility: Joseph Ducuing Hospital - Médecine interne
city: Toulouse
country: France
facility: Toulouse university Hospital - Larrey Dermatologie
city: Toulouse
country: France
facility: Toulouse University Hospital - Rhumatologie
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Toulouse
country: France
facility: University Hospital of Toulouse - Rangueil Médecine interne
city: Toulouse
country: France
facility: University hospital Toulouse - Purpan Médecine interne
Study officials:
affiliation: University Hospital, Toulouse
name: Laurent ALRIC, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
citation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.