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

NCT ID: NCT04392128

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2020-09-02

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

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 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)

Conditions

COVID19; Hematologic Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment arm

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).

Group Type: EXPERIMENTAL

Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Intervention Type: DRUG

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.

Azithromycin 250 MG Oral Capsule

Intervention Type: DRUG

Azithromycin is amacrolide antibiotic.

Control arm

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)

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo of Hydroxychloroquine Sulfate 200 MG \[Plaquenil\].

Placebo oral capsule

Intervention Type: DRUG

Placebo of Azithromycin capsules.

Interventions

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.

Intervention Type: DRUG

Azithromycin 250 MG Oral Capsule

Azithromycin is amacrolide antibiotic.

Intervention Type: DRUG

Placebo oral tablet

Placebo of Hydroxychloroquine Sulfate 200 MG \[Plaquenil\].

Intervention Type: DRUG

Placebo oral capsule

Placebo of Azithromycin capsules.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de Cancérologie Strasbourg Europe

Strasbourg, , France

Countries

France

Other Identifiers

2020-002002-45

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2020-005

Identifier Type: -

Identifier Source: org_study_id