Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
- Conditions
- COVID-19
- Registration Number
- NCT04452617
- Lead Sponsor
- Institut Mutualiste Montsouris
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death 30 days after admission in ICU
- Secondary Outcome Measures
Name Time Method assessment of QTc interval prolongation during the treatment period compared to baseline ECG daily QTc (corrected QT interval) \> 500 ms and ΔQTc \> 60 ms
Trial Locations
- Locations (1)
Institut Mutualiste Montsouris
🇫🇷Paris, France