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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452617
Recruitment Status : Completed
First Posted : June 30, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Brief 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.


Condition or disease
COVID-19

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
Actual Study Start Date : March 19, 2020
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death [ Time Frame: 30 days after admission in ICU ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452617


Locations
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France
Institut Mutualiste Montsouris
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Investigators
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Principal Investigator: Lyes KNANI, Doctor Institut Mutualiste Montsouris
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Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT04452617    
Other Study ID Numbers: REA-03-2020
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Mutualiste Montsouris:
hydroxychloroquine
ADRS
azithromycine
torsade de pointe
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes