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Completed

NCT Number: NCT04481633

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges university Hospital, Limoges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID 19 serology

Diagnostic Test

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

COVID 19 Self-Questionnaire

Other

COVID 19 Self-Questionnaire

Primary outcomes

  1. Rate of patients with positive anti-COVID19 serology

    Time frame: Day 1

    Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.

Secondary outcomes

  1. Rate of patients with symptomatic or severe (hospitalization) form of infection

    Time frame: Day 1

    Rate of patients with symptomatic or severe (hospitalization) form of infection.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: PREPCOV

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2020
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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