Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04452617|
Recruitment Status : Completed
First Posted : June 30, 2020
Last Update Posted : September 1, 2020
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.
Many raised concerns regarding the potential cardiac toxicity of this association.
The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.
The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19|
|Actual Study Start Date :||March 19, 2020|
|Actual Primary Completion Date :||April 8, 2020|
|Actual Study Completion Date :||July 1, 2020|
- occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death [ Time Frame: 30 days after admission in ICU ]
- assessment of QTc interval prolongation during the treatment period compared to baseline ECG [ Time Frame: daily ]QTc (corrected QT interval) > 500 ms and ΔQTc > 60 ms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452617
|Institut Mutualiste Montsouris|
|Paris, France, 75014|
|Principal Investigator:||Lyes KNANI, Doctor||Institut Mutualiste Montsouris|