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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COVID 19 serology
COVID 19 Self-Questionnaire
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring lupus erythematous disease, prophylaxis, pre-emptive therapy, Hydroxy-Chloroquine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Limoges university Hospital
  • Montpellier University Hospital
  • Pitié Salpêtrière Hospital - Hépatologie
  • Pitié Salpêtrière Hospital - Médecine interne
  • Haut-Lévêque Hospital - Gastro-entérologie
  • Haut-Lévêque Hospital - Médecine interne
  • Joseph Ducuing Hospital - Médecine interneRecruiting
  • Toulouse university Hospital - Larrey DermatologieRecruiting
  • Toulouse University Hospital - RhumatologieRecruiting
  • Toulouse University HospitalRecruiting
  • University Hospital of Toulouse - Rangueil Médecine interneRecruiting
  • University hospital Toulouse - Purpan Médecine interneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient treated with Hydroxy-chloroquine

Patient without treatment with Hydroxy-chloroquine

Arm Description

patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)

patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2020
Last Updated
August 31, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04481633
Brief Title
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
Acronym
PREPCOV
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
lupus erythematous disease, prophylaxis, pre-emptive therapy, Hydroxy-Chloroquine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient treated with Hydroxy-chloroquine
Arm Type
Other
Arm Description
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
Arm Title
Patient without treatment with Hydroxy-chloroquine
Arm Type
Other
Arm Description
patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
Intervention Type
Diagnostic Test
Intervention Name(s)
COVID 19 serology
Intervention Description
Diagnosis of Covid-19 past infection will be made by serology
Intervention Type
Other
Intervention Name(s)
COVID 19 Self-Questionnaire
Intervention Description
COVID 19 Self-Questionnaire
Primary Outcome Measure Information:
Title
Rate of patients with positive anti-COVID19 serology
Description
Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Rate of patients with symptomatic or severe (hospitalization) form of infection
Description
Rate of patients with symptomatic or severe (hospitalization) form of infection.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent ALRIC, Pr
Phone
05 61 32 29 09
Ext
+33
Email
alric.l@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory PUGNET, Pr
Phone
(0)5 61 77 71 26
Ext
+33
Email
pugnet.g@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent ALRIC, Pr
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limoges university Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure FAUCHAIS, Pr
Phone
(0)5 55 05 80 61
Ext
+33
Email
mailto:anne-laure.fauchais@unilim.fr
First Name & Middle Initial & Last Name & Degree
Anne-Laure FAUCHAIS, Pr
First Name & Middle Initial & Last Name & Degree
Kim LY, Dr
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
31295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges-Philippe PAGEAUX, Pr
Phone
(0)4 67 33 73 81
Ext
+33
Email
mailto:gp-pageaux@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Georges-Philippe PAGEAUX, Pr
First Name & Middle Initial & Last Name & Degree
Stéphanie FAURE, Dr
Facility Name
Pitié Salpêtrière Hospital - Hépatologie
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal LEBRAY, Dr
Phone
01 42 53 05 96
Ext
+33
Email
Pascal.lebray@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pascal LEBRAY, Dr
First Name & Middle Initial & Last Name & Degree
Edouard LARREY, Dr
Facility Name
Pitié Salpêtrière Hospital - Médecine interne
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice CACOUB, Pr
Phone
01 42 17 80 27.
Ext
+33
Email
patrice.cacoub@aphp.fr
First Name & Middle Initial & Last Name & Degree
Patrice CACOUB, Pr
First Name & Middle Initial & Last Name & Degree
Mathieu VAUTIER, Dr
Facility Name
Haut-Lévêque Hospital - Gastro-entérologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN, Pr
Phone
(0)5 57 65 64 39
Ext
+33
Email
mailto:victor.deledinghen@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN, Pr
First Name & Middle Initial & Last Name & Degree
Marie IRLES-DEPE, Dr
Facility Name
Haut-Lévêque Hospital - Médecine interne
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Pr
Phone
(0)5 57 65 64 83
Ext
+33
Email
mailto:jean-francois.viallard@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Jean-François VIALLARD, Pr
First Name & Middle Initial & Last Name & Degree
Estibaliz LAZARO, Pr
Facility Name
Joseph Ducuing Hospital - Médecine interne
City
Toulouse
ZIP/Postal Code
31027
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin MICHAUD, Pr
Phone
(0)5 61 77 34 48
Ext
+33
Email
mailto:mmichaud@hjd.asso.fr
First Name & Middle Initial & Last Name & Degree
Martin MICHAUD, Pr
First Name & Middle Initial & Last Name & Degree
Francis GACHES, Dr
Facility Name
Toulouse university Hospital - Larrey Dermatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carle PAUL, Pr
Phone
(0)5 67 77 81 20
Ext
+33
Email
paul.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Carle PAUL, PR
First Name & Middle Initial & Last Name & Degree
Christina LIVIDEANU, DR
Facility Name
Toulouse University Hospital - Rhumatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud CONSTANTIN, Pr
Phone
056177696
Ext
+33
Email
mailto:constantin.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Arnaud CONSTANTIN, Pr
First Name & Middle Initial & Last Name & Degree
Adeline RUYSSEN-WITRAND, Pr
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique CHAUVEAU, Pr
Phone
(0)5 61 32 32 83
Ext
+33
Email
mailto:chauveau.d@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Dominique CHAUVEAU, Pr
First Name & Middle Initial & Last Name & Degree
David RIBES, Dr
Facility Name
University Hospital of Toulouse - Rangueil Médecine interne
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent ALRIC, Pr
Phone
05 61 32 35 95
Ext
+33
Email
alric.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Gregory PUGNET, Pr
Phone
05 61 77 71 26
Ext
+33
Email
pugnet.g@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Laurent ALRIC, Pr
First Name & Middle Initial & Last Name & Degree
Gregory PUGNET, Pr
Facility Name
University hospital Toulouse - Purpan Médecine interne
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent SAILLER, Pr
Phone
0561772278
Ext
+33
Email
sailler.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Laurent SAILLER, Pr
First Name & Middle Initial & Last Name & Degree
Guillaume MOULIS, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32194981
Citation
Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020. No abstract available.
Results Reference
background
PubMed Identifier
32171076
Citation
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
Results Reference
background
PubMed Identifier
31995857
Citation
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
Results Reference
background

Learn more about this trial

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

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