Clinical trial · Interventional
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)
Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): competent authority decision
Summary
Brief summary (as posted)
The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID19 | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azithromycin 250 MG Oral Capsule | Drug | — | UNRESOLVED |
| Hydroxychloroquine Sulfate 200 MG [Plaquenil] | Drug | Hydroxychloroquine | ALIAS |
| Placebo oral capsule | Drug | — | UNRESOLVED |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 (2 capsules taken at the same time) then 250mg per day (1 capsule per day) during 4 days).
- interventionNames
- Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
- Drug: Azithromycin 250 MG Oral Capsule
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules taken at the same time at day 1, then 1 capsule per day during 4 days)
- interventionNames
- Drug: Placebo oral tablet
- Drug: Placebo oral capsule
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older patients * Patient with hematologic malignancy who received or not hematopoietic stem cell transplantation * Non severe Covid-19 disease * PCR-confirmed COVID-19 disease by a nasopharyngeal swab * Life-expectancy related to the hematologic malignancy of at least 1 month * Men or women of child-bearing potential accepting to use effective contraception during and until 8 months after the end of the study treatment Exclusion Criteria: * Patients with severe form of COVID-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation * Previous treatment with hydroxychloroquine or azithromycine for Covid-19 infection * QTc interval greater than 480 ms * Hypersensibility to hydroxychloroquine or azithromycine * Retinopathy * TGO or TGP geater than 5 x the normal upper limit * Creatinine clearance lower than 30 ml/min * Concomitant treatment that may lead to prolongation of the QT space * Concomitant treatment with dihydroergotamine, ergotamine, cisapride or colchicine * Known G6PD deficiency
References
Publications (0)
Data not yet available