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

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 8, 2020

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Mutualiste Montsouris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lyes KNANI, Doctor, Principal Investigator, Institut Mutualiste Montsouris

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