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 |
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Recruitment Status :
Recruiting
First Posted : July 22, 2020
Last Update Posted : September 8, 2021
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Sponsor:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
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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 |
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 (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 : | March 2022 |
| Estimated Study Completion Date : | March 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Patient treated with Hydroxy-chloroquine
patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400)
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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 |
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Patient without treatment with Hydroxy-chloroquine
patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants
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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 :
- 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 :
- 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 immunosuppressants in combination with Hydroxy-Chloroquine.
- COVID19 diagnostic questionnaire and available serology result.
Group without hydroxychloroquine treatment (HC-) :
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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.
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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
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
| 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
| 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
| Principal Investigator: | Laurent ALRIC, Pr | University Hospital, Toulouse |
Publications:
| 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: | September 8, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital, Toulouse:
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lupus erythematous disease prophylaxis pre-emptive therapy Hydroxy-Chloroquine |
Additional relevant MeSH terms:
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COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |