COVID-19PREPCOVNCT04481633
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
A study testing COVID 19 serology and COVID 19 Self-Questionnaire in people with COVID-19, run by University Hospital, Toulouse at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID 19 serology and COVID 19 Self-Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 12 sitesFrance
- Study dates
- 9 Sep 2020to 6 Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- --> 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Limoges university Hospital
Limoges, 87042
Montpellier University Hospital
Montpellier, 31295
Pitié Salpêtrière Hospital - Hépatologie
Paris, 75651
Pitié Salpêtrière Hospital - Médecine interne
Paris, 75651
Haut-Lévêque Hospital - Gastro-entérologie
Pessac, 33604
Haut-Lévêque Hospital - Médecine interne
Pessac, 33604
Joseph Ducuing Hospital - Médecine interne
Toulouse, 31027
Toulouse university Hospital - Larrey Dermatologie
Toulouse, 31059
Toulouse University Hospital - Rhumatologie
Toulouse, 31059
Toulouse University Hospital
Toulouse, 31059
University Hospital of Toulouse - Rangueil Médecine interne
Toulouse, 31059
University hospital Toulouse - Purpan Médecine interne
Toulouse, 31059
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- COVID 19 serology, COVID 19 Self-Questionnaire
- Keywords
- lupus erythematous disease, prophylaxis, pre-emptive therapy, Hydroxy-Chloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID 19 serologyDiagnostic test
Diagnosis of Covid-19 past infection will be made by serology
COVID 19 Self-QuestionnaireOther
COVID 19 Self-Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with Hydroxy-chloroquine | Other | patients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400) Receives: 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 Receives: Diagnostic Test: COVID 19 serology; Other: COVID 19 Self-Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Anti-SARS-CoV-2 Serology
Number of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine
Measured: 12 months post inclusion
Secondary outcomes (1)
Number of Patients Who Experienced Symptomatic or Severe (Hospitalization) COVID-19 Infection
Percentage of patients who experienced symptomatic or severe (hospitalization) COVID-19 infection, as determined by the self-administered questionnaire and medical consultation.
Each subject will complete a self-administered questionnaire at the enrollment visit, describing the main symptoms of COVID-19 infection by answering "yes" or "no" to the various items. The physician will then conduct a medical assessment of the symptoms and their severity.
Measured: From inclusion until the end of the study (at M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start9 Sep 2020
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent ALRIC, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481633
- Sponsor's protocol ID
- RC31/20/0186
- Other IDs
- 2020-A01906-33
- Acronym
- PREPCOV
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2020
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40044500