Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002002-45 | EudraCT Number |
Not provided
Not provided
competent authority decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evolution | Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia) | up to 3 months |
| Proportion of patients progressing to a severe form |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie Strasbourg Europe | Strasbourg | 67033 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Azithromycin 250 MG Oral Capsule | Drug | Azithromycin is amacrolide antibiotic. |
|
| Placebo oral tablet | Drug | Placebo of Hydroxychloroquine Sulfate 200 MG [Plaquenil]. |
|
| Placebo oral capsule | Drug | Placebo of Azithromycin capsules. |
|
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
| up to 3 months |
| Mortality | Date and cause of death | up to 1 and 3 months |
| Evaluation of viral load drop | 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 | at day 10 |
| Tolerance of study treatment | 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) | up to 3 months |
| Evaluation of the seroconversion | Collection of serum to realize serological tests | at inclusion, day 10, day 30 and day 90 after treatment |
| NK immunological study | Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells. | at day 10 and day 30 after treatment |
| Hospitalisation duration | Duration of hospitalisation (conventional, intensive care, reanimation) | up to 3 months |
| Impact of the study treatment on the treatment of the hematological disease | Patient follow-up during 3 months : hematological status and associated therapy | up to 3 months |
| Monitoring of the QT space | ECG (using connected machine to allow monitoring at home) | at inclusion, day 2, day 5, day 10 |
| Dosage of residual concentration of azithromycine and hydroxychloroquine. | Dosage of residual concentration of azithromycine and hydroxychloroquine. | at day 5 and day 10 |
| T immunological study | Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells. | at day 10 and day 30 after treatment |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided