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
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: April 8, 2020
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.
- cardiac conduction disorders
- continuous anti-arrhythmic therapy
- heart failure
- chronic renal failure
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Institut Mutualiste Montsouris
- Provider of Information About this Clinical Study
- Overall Official(s)
- Lyes KNANI, Doctor, Principal Investigator, Institut Mutualiste Montsouris
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