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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04452617

Enrollment

Registered

2020-06-30

Start date

2020-03-19

Completion date

2020-07-01

Last updated

2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

hydroxychloroquine, ADRS, azithromycine, torsade de pointe

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death	30 days after admission in ICU

Secondary

Measure	Time frame	Description
assessment of QTc interval prolongation during the treatment period compared to baseline ECG	daily	QTc (corrected QT interval) \> 500 ms and ΔQTc \> 60 ms

Countries

France

Outcome results