Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19

Institut Mutualiste Montsouris40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin. Exclusion Criteria: * cardiac conduction disorders * continuous anti-arrhythmic therapy * heart failure * chronic renal failure

Locations (1)

Institut Mutualiste Montsouris

Paris, France

Outcomes

Primary Outcomes

occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death

Time frame: 30 days after admission in ICU

Secondary Outcomes

assessment of QTc interval prolongation during the treatment period compared to baseline ECG

QTc (corrected QT interval) \> 500 ms and ΔQTc \> 60 ms

Time frame: daily