EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

University Hospital, Strasbourg, France

Overview

Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Sars-CoV-2, Community-Acquired Pneumonia,COVID-19

Interventions

Hydroxychloroquine and azithromycin treatment arm.DRUG

Patient allocated in this arm receive hydroxychloroquine and azithromycin for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5. For azithromycin, there is a loading dose of 500 mg per day at D1, followed by 250 mg per day D2-D5. Every patient receive as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).

HydroxychloroquineDRUG

Patient allocated in this arm receive hydroxychloroquine for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5. Every patient receives as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).

Control arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years old * Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab * CT scan suggestive of Sars-CoV-2 pneumonia Exclusion Criteria: * Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab * Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member * Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin) * Retinopathy or maculopathy * Porphyria * Severe renal failure (GFR less than 30 mL/min/m²) * Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L) * Hypomagnesiemia, ie less than 0,7 mmol/L * Severe cholestasis, cirrhosis or severe hepatic failure * Known cardiac medical history of congestive heart failure or myocardial infarction * Bradycardia less than 50 beats per minute * Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders * Blood disorders with history of hematopoietic stem cells allograft * Known history of G6PD deficiency * Pregnancy * Breastfeeding * Subject protected by law under guardianship of curatorship * Inability to take oral medications

Outcomes

Primary Outcomes

Rate of patients reaching a significant hypoxemia, in each arms.

A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.

Time frame: From day 0 to day 7

Data from ClinicalTrials.gov

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