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

Institut de cancérologie Strasbourg Europe

Status and phase: Withdrawn; Phase 2

Conditions: Hematologic Malignancy; COVID19

Treatments: Drug: Placebo oral capsule; Drug: Placebo oral tablet; Drug: Azithromycin 250 MG Oral Capsule; Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Study type: Interventional

Funder types: Other

Identifiers

NCT04392128

2020-005

2020-002002-45 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

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).

Treatment:

Drug: Azithromycin 250 MG Oral Capsule

Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Control arm

Placebo Comparator group

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)

Treatment:

Drug: Placebo oral tablet

Drug: Placebo oral capsule