BridgeMD
QUIDOSE. Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis
EU CTIS ID: 2024-516101-23-00
What this study is testing
To demonstrate the non-inferiority of hydroxychloroquine combined with low-dose corticosteroids versus medium-dose corticosteroid therapy in improving respiratory function at 6 months
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
- Glucose-6-Phosphate Dehydrogenase deficiency (acute hemodialysis risk)
- HIV positivity, active Hepatitis B or C
- Systemic corticosteroid or immunosuppressant use for at least 7 days in the previous 3 months inclusion/randomization
- History of hydroxychloroquine treatment for sarcoidosis
- Current pregnancy
See the full eligibility criteria
- 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
- 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)
- Glucose-6-Phosphate Dehydrogenase deficiency (acute hemodialysis risk)
- HIV positivity, active Hepatitis B or C
- Systemic corticosteroid or immunosuppressant use for at least 7 days in the previous 3 months inclusion/randomization
- History of hydroxychloroquine treatment for sarcoidosis
- Current pregnancy
- Breastfeeding
- Inability to respond to questionnaires despite aid
- Patient under guardianship or curatorship
- Patient under judicial protection
- Participation in another interventional therapeutic trial within 6 months before inclusion
- Cardiomyopathy with heart failure
- Other conditions affecting respiratory function: moderate to very severe COPD, uncontrolled asthma, obesity (BMI >30), fibrotic pulmonary disease, pulmonary neoplasia
- Hydroxychloroquine contraindications (hypersensitivity, severe retinal or cataract, unilateral blindness, myasthenia gravis, QTc prolongation, concurrent QT-prolonging drugs)
- Tamoxifen use
- Renal insufficiency with clearance <60ml/min
- History of retinopathy or maculopathy
- Corticosteroid contraindications (hypersensitivity, infections, evolving virosis, glaucoma, uncontrolled psychosis, live vaccines, uncontrolled diabetes, uncontrolled hypertension)
- Acute porphyria risk
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.