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

NCT04392128 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-09-04

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Azithromycin 250 MG Oral Capsule

Azithromycin is amacrolide antibiotic.

DRUG

Placebo oral tablet

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

DRUG

Placebo oral capsule

Placebo of Azithromycin capsules.

Sponsors & Collaborators

  • Institut de cancérologie Strasbourg Europe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2020-09-02
Completion
2020-09-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392128 on ClinicalTrials.gov