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Hydroxychloroquine

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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).

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)

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.

Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Azithromycin 250 MG Oral Capsule

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

Placebo oral tablet

Placebo oral capsule

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)

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

Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies

Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles \> or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles \< 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.

Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)

Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock

SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples

Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade \> 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)

Collection of serum to realize serological tests

Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.

Duration of hospitalisation (conventional, intensive care, reanimation)

Patient follow-up during 3 months : hematological status and associated therapy

ECG (using connected machine to allow monitoring at home)

Dosage of residual concentration of azithromycine and hydroxychloroquine.

Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)	NCT04392128	COVID19 Hematologic Mal...	Hydroxychloroqu... Azithromycin 25... Placebo oral ta... Placebo oral ca...	18 Years -	Institut de cancérologie Strasbourg Europe
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)	NCT04392128	COVID19 Hematologic Mal...	Hydroxychloroqu... Azithromycin 25... Placebo oral ta... Placebo oral ca...	18 Years -	Institut de cancérologie Strasbourg Europe

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