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

Not Applicable

• Conditions: COVID-19
• Interventions: Diagnostic Test: COVID 19 serology; Other: COVID 19 Self-Questionnaire

• Registration Number: NCT04481633
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2020-09-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient without treatment with Hydroxy-chloroquine	COVID 19 serology	patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
Patient treated with Hydroxy-chloroquine	COVID 19 Self-Questionnaire	patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
Patient treated with Hydroxy-chloroquine	COVID 19 serology	patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
Patient without treatment with Hydroxy-chloroquine	COVID 19 Self-Questionnaire	patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants

Primary Outcome Measures

Name	Time	Method
Rate of patients with positive anti-COVID19 serology	Day 1	Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.

Secondary Outcome Measures

Name	Time	Method
Rate of patients with symptomatic or severe (hospitalization) form of infection	Day 1	Rate of patients with symptomatic or severe (hospitalization) form of infection.

Trial Locations

Locations (12)

Pitié Salpêtrière Hospital - Hépatologie; 🇫🇷 Paris, France

Pitié Salpêtrière Hospital - Médecine interne; 🇫🇷 Paris, France

Haut-Lévêque Hospital - Gastro-entérologie; 🇫🇷 Pessac, France

University Hospital of Toulouse - Rangueil Médecine interne; 🇫🇷 Toulouse, France

University hospital Toulouse - Purpan Médecine interne; 🇫🇷 Toulouse, France

Limoges university Hospital; 🇫🇷 Limoges, France

Montpellier University Hospital; 🇫🇷 Montpellier, France

Haut-Lévêque Hospital - Médecine interne; 🇫🇷 Pessac, France

Toulouse University Hospital - Rhumatologie; 🇫🇷 Toulouse, France

Joseph Ducuing Hospital - Médecine interne; 🇫🇷 Toulouse, France

Toulouse university Hospital - Larrey Dermatologie; 🇫🇷 Toulouse, France

Toulouse University Hospital; 🇫🇷 Toulouse, France