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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01906-33 | Other Identifier | N° ID-RCB |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated with Hydroxy-chloroquine | Other | patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400) |
|
| Patient without treatment with Hydroxy-chloroquine | Other | patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID 19 serology | Diagnostic Test | Diagnosis of Covid-19 past infection will be made by serology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with positive anti-COVID19 serology | Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with symptomatic or severe (hospitalization) form of infection | Rate of patients with symptomatic or severe (hospitalization) form of infection. | Day 1 |
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Inclusion Criteria:
Group with hydroxychloroquine treatment (HC +):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent ALRIC, Pr | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limoges university Hospital | Limoges | 87042 | France | |||
| Montpellier University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32194981 | Background | 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. | |
| 32171076 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2026 | |
| Reset | May 14, 2026 |
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| COVID 19 Self-Questionnaire | Other | COVID 19 Self-Questionnaire |
|
| Montpellier |
| 31295 |
| France |
| Pitié Salpêtrière Hospital - Hépatologie | Paris | 75651 | France |
| Pitié Salpêtrière Hospital - Médecine interne | Paris | 75651 | France |
| Haut-Lévêque Hospital - Gastro-entérologie | Pessac | 33604 | France |
| Haut-Lévêque Hospital - Médecine interne | Pessac | 33604 | France |
| Joseph Ducuing Hospital - Médecine interne | Toulouse | 31027 | France |
| Toulouse university Hospital - Larrey Dermatologie | Toulouse | 31059 | France |
| Toulouse University Hospital - Rhumatologie | Toulouse | 31059 | France |
| Toulouse University Hospital | Toulouse | 31059 | France |
| University Hospital of Toulouse - Rangueil Médecine interne | Toulouse | 31059 | France |
| University hospital Toulouse - Purpan Médecine interne | Toulouse | 31059 | France |
| 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. |
| 31995857 | Background | 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. |
| 40044500 | Result | Alric L, Brusq C, Migueres M, Faure S, Lebray P, Viallard JF, Chauveau D, Sailler L, Berard E, Pugnet G, Cacoub P; Prepcov study. Evaluation of the effects of pre-exposure treatment with hydroxychloroquine on the risk of COVID-19 infection and on the efficacy of anti-COVID-19 vaccination during lupus or Gougerot-Sjogren's disease: Prepcov multicentre trial. Lupus Sci Med. 2025 Mar 5;12(1):e001435. doi: 10.1136/lupus-2024-001435. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2026 | May 14, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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