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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452617
• Other study ID #: REA-03-2020
• Status: Completed
• Start date: March 19, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death		30 days after admission in ICU
Secondary	assessment of QTc interval prolongation during the treatment period compared to baseline ECG	QTc (corrected QT interval) > 500 ms and ?QTc > 60 ms	daily