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Effects on the Qt Interval of COVID-19 Coronavirus Infection (QT-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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422535
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Matilde Zaballos, Hospital General Universitario Gregorio Marañon

Brief Summary:
The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

Condition or disease
Coronavirus Infection Intensive Care Patients

Detailed Description:

Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.

Relevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort
Critical care patients
Patients admitted to critical care units for COVID-19, where ECG records and relevant clinical information are available to assess the impact of the disease and its concomitant treatment on electrocardiographic parameters of ventricular repolarization



Primary Outcome Measures :
  1. Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection [ Time Frame: through study completion, an average of 1 year ]
    The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.


Secondary Outcome Measures :
  1. incidence of arrhythmias and impact of the COVI-drugs administered on QT interval [ Time Frame: through study completion, an average of 1 year ]

    To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units.

    To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.




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
  • Patients admitted to critical care units with COVID-19 infection
  • Ages between 18-80 years
  • Documentation in the clinical history sufficient to collect the data of interest to the study.
Criteria

Inclusion Criteria:

  • Patients admitted to intensive care units for COVID-19 infection with an ECG record

Exclusion Criteria:

  • Patients in critical care unit without COVID-19 infection

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): NCT04422535


Contacts
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Contact: Matilde Zaballos, MDPhD 0034657813987 mati@plagaro.net
Contact: Javier Hortal, MD PhD 915868367 javier.hortal@gmail.com

Locations
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Spain
Servicio de Anestesia, Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Matilde Zaballos, MD, PhD    0034915868367    mati@plagaro.net   
Sponsors and Collaborators
Matilde Zaballos
Investigators
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Study Chair: Javier Hortal, MD PhD Hospital Universitario Gregorio Marañon
Publications of Results:
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Responsible Party: Matilde Zaballos, specialist physician at Anesthesiology Department, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT04422535    
Other Study ID Numbers: QT-COVID-19
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: May 2020

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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 Matilde Zaballos, Hospital General Universitario Gregorio Marañon:
QT interval, ventricular repolarization
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases