Taking people in FrancePhase 3
Hydroxychloroquine with low-dose steroids compared with medium-dose steroids for lung sarcoidosis
Compares hydroxychloroquine plus low-dose steroids with medium-dose steroids for lung function in sarcoidosis.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Paris
- Where
- Angers, Aulnays-Sous-Bois, Bobigny Cedex, Bron, Caen, Creteil, Créteil, Dijon, Eaubonne, Evreux, Le Chesnay Rocquencourt, Le Mans Cedex 9, Lille Cedex, Lyon Cedex 04, Marseille, Melun, Montfermeil, Paris, Paris Cedex 10, Paris Cedex 13, Paris Cedex 18, Pessac, Pontoise, Rennes Cedex 9, Rouen, Saint-Herblain, St Denis Cedex, Strasbourg Cedex, Suresnes, Toulouse, and Tours Cedex 9, FranceSee the 32 sites
- Registry title
- QUIDOSE. Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 170 people, planned
- Started
- 28 Oct 2024
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional
- Record updated
- 7 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active sarcoidosis in the lungs that affects breathing. It compares hydroxychloroquine plus low-dose corticosteroids with medium-dose corticosteroids.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Pulmonary sarcoidosis that meets the ATS 2020 diagnostic criteria. Scans must show the lungs are active. FVC (a breathing test) must be ≤ 80% of predicted, or have dropped by ≥10% from the highest earlier FVC. People with FVC ≤ 90% of predicted can also join if their physical ability got much worse in the last year. At least one breathing symptom is needed: cough, shortness of breath or chest pain.
- Earlier treatment
- No systemic corticosteroids or immunosuppressants for at least 7 days in the previous 3 months. No earlier hydroxychloroquine for sarcoidosis.
Main reasons for not taking part
- Severe sarcoidosis needing urgent or high-dose corticosteroid treatment, for example in the heart, nerves, eyes, kidneys or liver
- G6PD deficiency, HIV, or active hepatitis B or C
- Pregnancy or breastfeeding
- Other lung or heart conditions, such as moderate to very severe COPD, uncontrolled asthma, BMI >30, lung fibrosis, lung cancer, or heart failure
- Kidney clearance <60ml/min, past retinopathy or maculopathy, or reasons that rule out hydroxychloroquine or corticosteroids
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Aged ≥18 and ≤80 years
- Pulmonary sarcoidosis meeting ATS 2020 AJRCCM diagnostic criteria ( (i) compatible presentation, (ii) non-necrotizing granuloma in one or more tissues, exclusion of alternative granulomatous diseases)
- Patient presenting : - Lung activity on imaging (e.g., micronodules, nodules, ground glass, consolidations, septal lines) - And FVC ≤ 80% pred and/or ≥10% absolute decline in FVC from the best FVC or FVC ≤ 90% pred with significant physical performance deterioration in the last year - And one or more respiratory symptom(s) among the following: cough, dyspnea, chest pain
- Effective contraception for women of childbearing potential until 8 months post-treatment
- Informed and signed consent
- Social security coverage
Who cannot take part
- Systemic corticosteroid or immunosuppressant use for at least 7 days in the previous 3 months inclusion/randomization
- Participation in another interventional therapeutic trial within 6 months before inclusion
- Severe sarcoidosis requiring immediate and urgent results and/or high-dose corticosteroids (severe/active neurological (except facial nerve involvement), cardiac, ophthalmic (except local treatment-responsive form), laryngeal, renal involvement, severe hypercalcemia, severe hepatic)
- HIV positivity, active Hepatitis B or C
- History of hydroxychloroquine treatment for sarcoidosis
- Cardiomyopathy with heart failure
- Other conditions affecting respiratory function: moderate to very severe COPD, uncontrolled asthma, obesity (BMI >30), fibrotic pulmonary disease, pulmonary neoplasia
- History of retinopathy or maculopathy
- Corticosteroid contraindications (hypersensitivity, infections, evolving virosis, glaucoma, uncontrolled psychosis, live vaccines, uncontrolled diabetes, uncontrolled hypertension)
- Glucose-6-Phosphate Dehydrogenase deficiency (acute hemodialysis risk)
- Hydroxychloroquine contraindications (hypersensitivity, severe retinal or cataract, unilateral blindness, myasthenia gravis, QTc prolongation, concurrent QT-prolonging drugs)
- Renal insufficiency with clearance <60ml/min
- Current pregnancy
- Breastfeeding
- Inability to respond to questionnaires despite aid
- Patient under guardianship or curatorship
- Patient under judicial protection
- Tamoxifen use
- Acute porphyria risk
Where in France
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Ctre Hospitalier Intercomm R BallangerAulnays-Sous-Bois, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny Cedex, FranceTaking people
- Hospices Civils de LyonBron, FranceTaking people
- Centre Hospitalier Universitaire de Caen NormandieCaen, FranceTaking people
- Assistance Publique Hopitaux De ParisCreteil, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Groupement Hospitalier Eaubonne Montmorency Simone VeilEaubonne, FranceTaking people
- Centre Hospitalier Eure-SeineEvreux, FranceTaking people
- Centre Hospitalier De VersaillesLe Chesnay Rocquencourt, FranceTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Hospices Civils De LyonLyon Cedex 04, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Groupe Hospitalier Du Sud Ile De FranceMelun, FranceTaking people
- Groupe Hospitalier Intercommunal Le Raincy MontfermeilMontfermeil, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire RouenRouen, FranceTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
- Centre Hospitalier General De St DenisSt Denis Cedex, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Hospital FochSuresnes, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceTaking people
About the trial
What the trial wants to find out
To demonstrate the non-inferiority of hydroxychloroquine combined with low-dose corticosteroids versus medium-dose corticosteroid therapy in improving respiratory function at 6 months
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- QUIDOSE. Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis.
- Plain-language title
- Hydroxychloroquine with low-dose steroids compared with medium-dose steroids for lung sarcoidosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 7 August 2026