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

Toulouse University Hospital

Status: Unknown

Conditions: COVID-19

Treatments: Other: COVID 19 Self-Questionnaire; Diagnostic Test: COVID 19 serology

Study type: Interventional

Funder types: Other

Identifiers

NCT04481633

RC31/20/0186

2020-A01906-33 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

Patient treated with Hydroxy-chloroquine

Other group

Description:

patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)

Treatment:

Diagnostic Test: COVID 19 serology

Other: COVID 19 Self-Questionnaire

Patient without treatment with Hydroxy-chloroquine

Other group

Description:

patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants

Treatment:

Diagnostic Test: COVID 19 serology

Other: COVID 19 Self-Questionnaire