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

NCT04481633 | Completed

• 2 other identifiers: RC31/20/01862020-A01906-33
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 12

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.

Conditions

COVID-19

Keywords

lupus erythematous disease; prophylaxis; pre-emptive therapy; Hydroxy-Chloroquine

Outcome Measures

Primary Outcomes (1)

• Rate of patients with positive anti-COVID19 serology

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

  Day 1

Secondary Outcomes (1)

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

  Day 1

Study Arms (2)

Patient treated with Hydroxy-chloroquine

OTHER

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

Diagnostic Test: COVID 19 serology; Other: COVID 19 Self-Questionnaire

Patient without treatment with Hydroxy-chloroquine

OTHER

patients without treatment with Hydroxy-Chloroquine with or without immunosuppressants

Diagnostic Test: COVID 19 serology; Other: COVID 19 Self-Questionnaire

Interventions

COVID 19 serology DIAGNOSTIC_TEST

Diagnosis of Covid-19 past infection will be made by serology

Patient treated with Hydroxy-chloroquine; Patient without treatment with Hydroxy-chloroquine

COVID 19 Self-Questionnaire OTHER

COVID 19 Self-Questionnaire

Patient treated with Hydroxy-chloroquine; Patient without treatment with Hydroxy-chloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (12)

Limoges university Hospital

Limoges, 87042, France

Location

Montpellier University Hospital

Montpellier, 31295, France

Location

Pitié Salpêtrière Hospital - Hépatologie

Paris, 75651, France

Location

Pitié Salpêtrière Hospital - Médecine interne

Paris, 75651, France

Location

Haut-Lévêque Hospital - Gastro-entérologie

Pessac, 33604, France

Location

Haut-Lévêque Hospital - Médecine interne

Pessac, 33604, France

Location

Joseph Ducuing Hospital - Médecine interne

Toulouse, 31027, France

Location

Toulouse university Hospital - Larrey Dermatologie

Toulouse, 31059, France

Location

Toulouse University Hospital - Rhumatologie

Toulouse, 31059, France

Location

Toulouse University Hospital

Toulouse, 31059, France

Location

University Hospital of Toulouse - Rangueil Médecine interne

Toulouse, 31059, France

Location

University hospital Toulouse - Purpan Médecine interne

Toulouse, 31059, France

Location

Related Publications (4)

• 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.

  PMID: 32194981 BACKGROUND

• 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.

  PMID: 32171076 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.

  PMID: 31995857 BACKGROUND

• 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.

  PMID: 40044500 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Officials

• Laurent ALRIC, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 22, 2020
• Study Start: September 9, 2020
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)