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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: COVID 19 serology; Other: COVID 19 Self-Questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 552
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Limoges University Hospital
  • Montpellier, France, 31295
    • Montpellier University Hospital
  • Paris, France, 75651
    • Pitié Salpêtrière Hospital - Hépatologie
  • Paris, France, 75651
    • Pitié Salpêtrière Hospital - Médecine interne
  • Pessac, France, 33604
    • Haut-Lévêque Hospital - Gastro-entérologie
  • Pessac, France, 33604
    • Haut-Lévêque Hospital - Médecine interne
  • Toulouse, France, 31059
    • Toulouse University Hospital
  • Toulouse, France, 31027
    • Joseph Ducuing Hospital - Médecine interne
  • Toulouse, France, 31059
    • Toulouse university Hospital - Larrey Dermatologie
  • Toulouse, France, 31059
    • Toulouse University Hospital - Rhumatologie
  • Toulouse, France, 31059
    • University Hospital of Toulouse - Rangueil Médecine interne
  • Toulouse, France, 31059
    • University hospital Toulouse - Purpan Médecine interne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient treated with Hydroxy-chloroquine; patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Laurent ALRIC, Pr, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prophylaxis; lupus erythematous disease; pre-emptive therapy; Hydroxy-Chloroquine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Serologic Tests; COVID-19 Testing; COVID-19 Serological Testing
• Other Study ID Numbers: RC31/20/0186; 2020-A01906-33 (Other Identifier: N° ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No