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

NCT04392128 | Withdrawn Phase 2 DMC

• 2 other identifiers: 2020-0052020-002002-45
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19; Hematologic Malignancy

Keywords

SARS-CoV-2; Hematologic malignancy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.

  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.

  5 days of treatment

Secondary Outcomes (12)

• Clinical evolution

  up to 3 months

• Proportion of patients progressing to a severe form

  up to 3 months

• Mortality

  up to 1 and 3 months

• Evaluation of viral load drop

  at day 10

• Tolerance of study treatment

  up to 3 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

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).

Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]; Drug: Azithromycin 250 MG Oral Capsule

Control arm

PLACEBO COMPARATOR

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)

Drug: Placebo oral tablet; Drug: Placebo oral capsule

Interventions

Hydroxychloroquine Sulfate 200 MG [Plaquenil] 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.

Treatment arm

Azithromycin 250 MG Oral Capsule DRUG

Azithromycin is amacrolide antibiotic.

Treatment arm

Placebo oral tablet DRUG

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

Control arm

Placebo oral capsule DRUG

Placebo of Azithromycin capsules.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de Cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

COVID-19; Hematologic Neoplasms

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 18, 2020
• Study Start: September 2, 2020
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)