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

I

Institut Mutualiste Montsouris

Status

Completed

Conditions

COVID-19

Study type

Observational

Funder types

Other

Identifiers

NCT04452617
REA-03-2020

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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