NCT04481633

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	COVID 19 serology	Diagnosis of Covid-19 past infection will be made by serology
OTHER	COVID 19 Self-Questionnaire	COVID 19 Self-Questionnaire

Timeline

• Start date: 2020-09-09
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2020-07-22
• Last updated: 2026-01-06

Locations

12 sites across 1 country: France