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

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

— TEACHCOVID  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04347512
• Other study ID #: 7783
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Hydroxychloroquine and azithromycin treatment arm.
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).
• Hydroxychloroquine
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
In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From day 0 to day 7