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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481633
• Other study ID #: RC31/20/0186
• Secondary ID: 2020-A01906-33
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: University Hospital, Toulouse
• Contact: Laurent ALRIC, Pr
• Phone: 05 61 32 29 09
• Email: alric.l[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

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

Locations

Country	Name	City	State
France	Limoges university Hospital	Limoges
France	Montpellier University Hospital	Montpellier
France	Pitié Salpêtrière Hospital - Hépatologie	Paris
France	Pitié Salpêtrière Hospital - Médecine interne	Paris
France	Haut-Lévêque Hospital - Gastro-entérologie	Pessac
France	Haut-Lévêque Hospital - Médecine interne	Pessac
France	Joseph Ducuing Hospital - Médecine interne	Toulouse
France	Toulouse University Hospital	Toulouse
France	Toulouse university Hospital - Larrey Dermatologie	Toulouse
France	Toulouse University Hospital - Rhumatologie	Toulouse
France	University Hospital of Toulouse - Rangueil Médecine interne	Toulouse
France	University hospital Toulouse - Purpan Médecine interne	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with positive anti-COVID19 serology	Rate of patients with positive anti-COVID19 serology with or without Hydroxy-Chloroquine.	Day 1
Secondary	Rate of patients with symptomatic or severe (hospitalization) form of infection	Rate of patients with symptomatic or severe (hospitalization) form of infection.	Day 1