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

I

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Withdrawn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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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