Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)

• Status: Withdrawn
• Trial end date: 2020-09-02
• Target enrollment: 0
• Participant gender: All

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 viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de cancérologie Strasbourg Europe
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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