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

Sponsor
Institut Mutualiste Montsouris (Other)
Overall Status
Completed
CT.gov ID
NCT04452617
Collaborator
(none)
40
Enrollment
1
Location
3.4
Actual Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 19, 2020
    Actual Primary Completion Date :
    Apr 8, 2020
    Actual Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. assessment of QTc interval prolongation during the treatment period compared to baseline ECG [daily]

      QTc (corrected QT interval) > 500 ms and ΔQTc > 60 ms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Mutualiste Montsouris Paris France 75014

    Sponsors and Collaborators

    • Institut Mutualiste Montsouris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Mutualiste Montsouris
    ClinicalTrials.gov Identifier:
    NCT04452617
    Other Study ID Numbers:
    • REA-03-2020
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Sep 1, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    COVID-19

    Study Results

    No Results Posted as of Sep 1, 2020