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

August 28, 2020 updated by: Institut Mutualiste Montsouris

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ):

  • HCQ administered at a daily dosage of 600mg in 3 doses for 10 days.
  • AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6 days.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Investigators

  • Principal Investigator: Lyes KNANI, Doctor, Institut Mutualiste Montsouris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2020

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REA-03-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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