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.
The study will evaluate the effect of the combination of hydroxychloroquine and azithromycine
versus placebo among 114 patients with COVID-19 and hematologic malignancy.
After randomization in 1:1 ratio, patients will receive either the study treatment or placebo
:
- Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3
tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day
during 4 days)
- 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 at day 1,
then 1 capsule per day during 4 days)
Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
Hydroxychloroquine is an anti-malarial drug also used as anti-inflammatory treatment for systemic lupus erythematosus and rheumatic disorders. HCQ also inhibits pH-dependant replication stages of diverse types of viruses including flavivirus, retrovirus and coronaviruses.
Drug: Azithromycin 250 MG Oral Capsule
Azithromycin is amacrolide antibiotic.
Drug: Placebo oral tablet
Placebo of Hydroxychloroquine Sulfate 200 MG [Plaquenil].
Drug: Placebo oral capsule
Placebo of Azithromycin capsules.
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
Institut de Cancérologie Strasbourg Europe
Strasbourg, France