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

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.

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Key information

Conditions

COVID-19 Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tachycardia Tachycardia, Ventricular Torsades de Pointes Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Mutualiste Montsouris

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death

Time frame: 30 days after admission in ICU

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 30, 2020
Registry last updated: Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed