NCT04392128

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-02
• Primary completion: 2020-09-02
• Completion: 2020-09-02
• First posted: 2020-05-18
• Last updated: 2020-09-04

Locations

1 site across 1 country: France