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

August 31, 2021 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Limoges, France, 87042
        • Not yet recruiting
        • Limoges university hospital
        • Contact:
        • Principal Investigator:
          • Anne-Laure FAUCHAIS, Pr
        • Sub-Investigator:
          • Kim LY, Dr
      • Montpellier, France, 31295
        • Not yet recruiting
        • Montpellier University Hospital
        • Contact:
        • Principal Investigator:
          • Georges-Philippe PAGEAUX, Pr
        • Sub-Investigator:
          • Stéphanie FAURE, Dr
      • Paris, France, 75651
        • Not yet recruiting
        • Pitié Salpêtrière Hospital - Hépatologie
        • Contact:
        • Principal Investigator:
          • Pascal LEBRAY, Dr
        • Sub-Investigator:
          • Edouard LARREY, Dr
      • Paris, France, 75651
        • Not yet recruiting
        • Pitié Salpêtrière Hospital - Médecine interne
        • Contact:
        • Sub-Investigator:
          • Mathieu VAUTIER, Dr
      • Pessac, France, 33604
        • Not yet recruiting
        • Haut-Lévêque Hospital - Gastro-entérologie
        • Contact:
        • Principal Investigator:
          • Victor DE LEDINGHEN, Pr
        • Sub-Investigator:
          • Marie IRLES-DEPE, Dr
      • Pessac, France, 33604
        • Not yet recruiting
        • Haut-Lévêque Hospital - Médecine interne
        • Contact:
        • Sub-Investigator:
          • Estibaliz LAZARO, Pr
      • Toulouse, France, 31059
        • Recruiting
        • Toulouse University Hospital
        • Contact:
        • Principal Investigator:
          • Dominique CHAUVEAU, Pr
        • Sub-Investigator:
          • David RIBES, Dr
      • Toulouse, France, 31027
        • Recruiting
        • Joseph Ducuing Hospital - Médecine interne
        • Contact:
        • Principal Investigator:
          • Martin MICHAUD, Pr
        • Sub-Investigator:
          • Francis GACHES, Dr
      • Toulouse, France, 31059
        • Recruiting
        • Toulouse university Hospital - Larrey Dermatologie
        • Contact:
        • Principal Investigator:
          • Carle PAUL, PR
        • Sub-Investigator:
          • Christina LIVIDEANU, DR
      • Toulouse, France, 31059
        • Recruiting
        • Toulouse University Hospital - Rhumatologie
        • Contact:
        • Principal Investigator:
          • Arnaud CONSTANTIN, Pr
        • Sub-Investigator:
          • Adeline RUYSSEN-WITRAND, Pr
      • Toulouse, France, 31059
        • Recruiting
        • University Hospital of Toulouse - Rangueil Médecine interne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurent ALRIC, Pr
        • Sub-Investigator:
          • Gregory PUGNET, Pr
      • Toulouse, France, 31059
        • Recruiting
        • University hospital Toulouse - Purpan Médecine interne
        • Contact:
        • Principal Investigator:
          • Laurent SAILLER, Pr
        • Sub-Investigator:
          • Guillaume MOULIS, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient treated with Hydroxy-chloroquine
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
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
OTHER: Patient without treatment with Hydroxy-chloroquine
patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Laurent ALRIC, Pr, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2020

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0186
  • 2020-A01906-33 (OTHER: N° ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on COVID 19 serology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe