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

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ClinicalTrials.gov Identifier: NCT04481633
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Diagnostic Test: COVID 19 serology Other: COVID 19 Self-Questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Patient treated with Hydroxy-chloroquine
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)Azathioprine or Methotrexate (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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Azathioprine or Methotrexate 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, Azathioprine or Methotrexate or other 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 Azathioprine (autoimmune hepatitis or LED/SGJ)) or Methotrexate (LED/SGJ) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481633


Contacts
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Contact: Laurent ALRIC, Pr 05 61 32 29 09 ext +33 alric.l@chu-toulouse.fr
Contact: Gregory PUGNET, Pr (0)5 61 77 71 26 ext +33 pugnet.g@chu-toulouse.fr

Locations
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France
Limoges university Hospital Not yet recruiting
Limoges, France, 87042
Contact: Anne-Laure FAUCHAIS, Pr    (0)5 55 05 80 61 ext +33    mailto:anne-laure.fauchais@unilim.fr   
Principal Investigator: Anne-Laure FAUCHAIS, Pr         
Sub-Investigator: Kim LY, Dr         
Montpellier University Hospital Not yet recruiting
Montpellier, France, 31295
Contact: Georges-Philippe PAGEAUX, Pr    (0)4 67 33 73 81 ext +33    mailto:gp-pageaux@chu-montpellier.fr   
Principal Investigator: Georges-Philippe PAGEAUX, Pr         
Sub-Investigator: Stéphanie FAURE, Dr         
Pitié Salpêtrière Hospital - Hépatologie Not yet recruiting
Paris, France, 75651
Contact: Pascal LEBRAY, Dr    01 42 53 05 96 ext +33    Pascal.lebray@aphp.fr   
Principal Investigator: Pascal LEBRAY, Dr         
Sub-Investigator: Edouard LARREY, Dr         
Pitié Salpêtrière Hospital - Médecine interne Not yet recruiting
Paris, France, 75651
Contact: Patrice CACOUB, Pr    01 42 17 80 27. ext +33    patrice.cacoub@aphp.fr   
Principal Investigator: Patrice CACOUB, Pr         
Sub-Investigator: Mathieu VAUTIER, Dr         
Haut-Lévêque Hospital - Gastro-entérologie Not yet recruiting
Pessac, France, 33604
Contact: Victor DE LEDINGHEN, Pr    (0)5 57 65 64 39 ext +33    mailto:victor.deledinghen@chu-bordeaux.fr   
Principal Investigator: Victor DE LEDINGHEN, Pr         
Sub-Investigator: Marie IRLES-DEPE, Dr         
Haut-Lévêque Hospital - Médecine interne Not yet recruiting
Pessac, France, 33604
Contact: Jean-François VIALLARD, Pr    (0)5 57 65 64 83 ext +33    mailto:jean-francois.viallard@chu-bordeaux.fr   
Principal Investigator: Jean-François VIALLARD, Pr         
Sub-Investigator: Estibaliz LAZARO, Pr         
Joseph Ducuing Hospital - Médecine interne Recruiting
Toulouse, France, 31027
Contact: Martin MICHAUD, Pr    (0)5 61 77 34 48 ext +33    mailto:mmichaud@hjd.asso.fr   
Principal Investigator: Martin MICHAUD, Pr         
Sub-Investigator: Francis GACHES, Dr         
Toulouse university Hospital - Larrey Dermatologie Recruiting
Toulouse, France, 31059
Contact: Carle PAUL, Pr    (0)5 67 77 81 20 ext +33    paul.c@chu-toulouse.fr   
Principal Investigator: Carle PAUL, PR         
Sub-Investigator: Christina LIVIDEANU, DR         
Toulouse University Hospital - Rhumatologie Recruiting
Toulouse, France, 31059
Contact: Arnaud CONSTANTIN, Pr    056177696 ext +33    mailto:constantin.a@chu-toulouse.fr   
Principal Investigator: Arnaud CONSTANTIN, Pr         
Sub-Investigator: Adeline RUYSSEN-WITRAND, Pr         
Toulouse University Hospital Recruiting
Toulouse, France, 31059
Contact: Dominique CHAUVEAU, Pr    (0)5 61 32 32 83 ext +33    mailto:chauveau.d@chu-toulouse.fr   
Principal Investigator: Dominique CHAUVEAU, Pr         
Sub-Investigator: David RIBES, Dr         
University Hospital of Toulouse - Rangueil Médecine interne Recruiting
Toulouse, France, 31059
Contact: Laurent ALRIC, Pr    05 61 32 35 95 ext +33    alric.l@chu-toulouse.fr   
Contact: Gregory PUGNET, Pr    05 61 77 71 26 ext +33    pugnet.g@chu-toulouse.fr   
Principal Investigator: Laurent ALRIC, Pr         
Sub-Investigator: Gregory PUGNET, Pr         
University hospital Toulouse - Purpan Médecine interne Recruiting
Toulouse, France, 31059
Contact: Laurent SAILLER, Pr    0561772278 ext +33    sailler.l@chu-toulouse.fr   
Principal Investigator: Laurent SAILLER, Pr         
Sub-Investigator: Guillaume MOULIS, Dr         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Laurent ALRIC, Pr University Hospital, Toulouse
Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04481633    
Other Study ID Numbers: RC31/20/0186
2020-A01906-33 ( Other Identifier: N° ID-RCB )
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
lupus erythematous disease
prophylaxis
pre-emptive therapy
Hydroxy-Chloroquine
Additional relevant MeSH terms:
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Infection