QUIDOSE. Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis

Ki vehet részt

• 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

Ki nem vehet részt

• 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