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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 15Show fewer
- --> 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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04481633
- Acronym / sponsor ID
- PREPCOV / RC31/20/0186
- Conditions
- COVID-19
- Keywords
- lupus erythematous disease, prophylaxis, pre-emptive therapy, Hydroxy-Chloroquine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient treated with Hydroxy-chloroquine | Other | Diagnostic Test: COVID 19 serology, Other: COVID 19 Self-Questionnairepatients treated with Hydroxy-Chloroquine (HC) with or without immunosuppressants (IS)(HC+ group, n=400) |
| Patient without treatment with Hydroxy-chloroquine | Other | Diagnostic Test: COVID 19 serology, Other: COVID 19 Self-Questionnairepatients without treatment with Hydroxy-Chloroquine with or without immunosuppressants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- No Hydroxy-Chloroquine intake for more than 12 months
- --> HC- without an immunosuppressant
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID 19 serologyDiagnosis of Covid-19 past infection will be made by serology | Diagnostic test | Patient treated with Hydroxy-chloroquine, Patient without treatment with Hydroxy-chloroquine |
| COVID 19 Self-QuestionnaireCOVID 19 Self-Questionnaire | Other | Patient treated with Hydroxy-chloroquine, Patient without treatment with Hydroxy-chloroquine |
Primary outcome
Number of Participants With Positive Anti-SARS-CoV-2 Serology
Time frame: 12 months post inclusion
Number of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine
1 secondary outcome
Number of Patients Who Experienced Symptomatic or Severe (Hospitalization) COVID-19 Infection
Time frame: From inclusion until the end of the study (at M12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40044500Alric 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent ALRIC, Pr principal investigator
University Hospital, Toulouse
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Positive Anti-SARS-CoV-2 Serology (time frame: 12 months post inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.