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Lupus drug hydroxychloroquine tested as COVID-19 shield

NCT ID NCT04481633

Prevention Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This completed study looked at whether lupus patients already taking hydroxychloroquine long-term had a lower risk of catching COVID-19 or developing severe symptoms. Researchers compared 552 patients who either took the drug or did not, using blood tests and questionnaires. The goal was to see if the drug offered any real-world protection during the pandemic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydroxychloroquine
What this could lead to
If it works, this could suggest that hydroxychloroquine helps protect people with autoimmune diseases from COVID-19 infection or severe illness.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to the general population, and earlier studies on hydroxychloroquine for COVID-19 showed mixed or no benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

547 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis primary biliary cholangitis Sjogren syndrome systemic lupus erythematosus COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19

Contacts and locations

Locations

  • Haut-Lévêque Hospital - Gastro-entérologie

    Pessac, 33604, France

  • Haut-Lévêque Hospital - Médecine interne

    Pessac, 33604, France

  • Joseph Ducuing Hospital - Médecine interne

    Toulouse, 31027, France

  • Limoges university Hospital

    Limoges, 87042, France

  • Montpellier University Hospital

    Montpellier, 31295, France

  • Pitié Salpêtrière Hospital - Hépatologie

    Paris, 75651, France

  • Pitié Salpêtrière Hospital - Médecine interne

    Paris, 75651, France

  • Toulouse University Hospital

    Toulouse, 31059, France

  • Toulouse University Hospital - Rhumatologie

    Toulouse, 31059, France

  • Toulouse university Hospital - Larrey Dermatologie

    Toulouse, 31059, France

  • University Hospital of Toulouse - Rangueil Médecine interne

    Toulouse, 31059, France

  • University hospital Toulouse - Purpan Médecine interne

    Toulouse, 31059, France

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