Status:
WITHDRAWN
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Conditions:
COVID19
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 vir...
Detailed Description
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04392128
Start Date
September 2 2020
End Date
September 2 2020
Last Update
September 4 2020
Active Locations (1)
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1
Institut de Cancérologie Strasbourg Europe
Strasbourg, France, 67033