<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422535</url>
  </required_header>
  <id_info>
    <org_study_id>QT-COVID-19</org_study_id>
    <nct_id>NCT04422535</nct_id>
  </id_info>
  <brief_title>Effects on the Qt Interval of COVID-19 Coronavirus Infection</brief_title>
  <acronym>QT-COVID-19</acronym>
  <official_title>Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Matilde Zaballos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aims to evaluate the impact of COVID-19 disease and its treatment on&#xD;
      ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to&#xD;
      the critical care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a&#xD;
      broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract&#xD;
      disease and severe viral pneumonia with respiratory failure and even death, with many&#xD;
      patients hospitalized with pneumonia. In addition, the infection can have a direct impact on&#xD;
      cardiovascular disease including the development of arrhythmias, although the exact incidence&#xD;
      is not known. Treatments administered for COVID-19 infection have the potential to produce&#xD;
      adverse cardiovascular effects including prolongation of the QT interval and development of&#xD;
      arrhythmias.&#xD;
&#xD;
      Relevant clinical data that may affect the QT interval and specifically the medication the&#xD;
      patient has received will be recorded. The specific treatment administered for COVID-19 will&#xD;
      be recorded as the concomitant medication of the critical patient that may have an impact on&#xD;
      the QT interval. Analytical data will also be collected on plasma levels of ions such as&#xD;
      potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and&#xD;
      cardiac markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of arrhythmias and impact of the COVI-drugs administered on QT interval</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units.&#xD;
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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Intensive Care Patients</condition>
  <arm_group>
    <arm_group_label>Critical care patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients admitted to critical care units with COVID-19 infection&#xD;
&#xD;
          -  Ages between 18-80 years&#xD;
&#xD;
          -  Documentation in the clinical history sufficient to collect the data of interest to&#xD;
             the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to intensive care units for COVID-19 infection with an ECG record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in critical care unit without COVID-19 infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Hortal, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario Gregorio Marañon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matilde Zaballos, MDPhD</last_name>
    <phone>0034657813987</phone>
    <email>mati@plagaro.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Javier Hortal, MD PhD</last_name>
    <phone>915868367</phone>
    <email>javier.hortal@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Servicio de Anestesia, Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matilde Zaballos, MD, PhD</last_name>
      <phone>0034915868367</phone>
      <email>mati@plagaro.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Fernandes FM, Silva EP, Martins RR, Oliveira AG. QTc interval prolongation in critically ill patients: Prevalence, risk factors and associated medications. PLoS One. 2018 Jun 13;13(6):e0199028. doi: 10.1371/journal.pone.0199028. eCollection 2018.</citation>
    <PMID>29898002</PMID>
  </results_reference>
  <results_reference>
    <citation>Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Drew BJ. How many patients need QT interval monitoring in critical care units? Preliminary report of the QT in Practice study. J Electrocardiol. 2010 Nov-Dec;43(6):572-6. doi: 10.1016/j.jelectrocard.2010.05.016.</citation>
    <PMID>21040827</PMID>
  </results_reference>
  <results_reference>
    <citation>Gowda RM, Khan IA, Wilbur SL, Vasavada BC, Sacchi TJ. Torsade de pointes: the clinical considerations. Int J Cardiol. 2004 Jul;96(1):1-6. doi: 10.1016/j.ijcard.2003.04.055.</citation>
    <PMID>15203254</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </results_reference>
  <results_reference>
    <citation>Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.</citation>
    <PMID>32211816</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Matilde Zaballos</investigator_full_name>
    <investigator_title>specialist physician at Anesthesiology Department</investigator_title>
  </responsible_party>
  <keyword>QT interval, ventricular repolarization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422535
org study id: QT-COVID-19
nct id: NCT04422535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: 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
description: 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.
measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval
time frame: through study completion, an average of 1 year
description: 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.
arm group label: Critical care patients
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Hortal, MD PhD
role: Study Chair
affiliation: Hospital Universitario Gregorio Marañon
last name: Matilde Zaballos, MDPhD
phone: 0034657813987
email: mati@plagaro.net
last name: Javier Hortal, MD PhD
phone: 915868367
email: javier.hortal@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
citation: Fernandes FM, Silva EP, Martins RR, Oliveira AG. QTc interval prolongation in critically ill patients: Prevalence, risk factors and associated medications. PLoS One. 2018 Jun 13;13(6):e0199028. doi: 10.1371/journal.pone.0199028. eCollection 2018.
PMID: 29898002
citation: Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Drew BJ. How many patients need QT interval monitoring in critical care units? Preliminary report of the QT in Practice study. J Electrocardiol. 2010 Nov-Dec;43(6):572-6. doi: 10.1016/j.jelectrocard.2010.05.016.
PMID: 21040827
citation: Gowda RM, Khan IA, Wilbur SL, Vasavada BC, Sacchi TJ. Torsade de pointes: the clinical considerations. Int J Cardiol. 2004 Jul;96(1):1-6. doi: 10.1016/j.ijcard.2003.04.055.
PMID: 15203254
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
PMID: 32211816
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Matilde Zaballos
investigator title: specialist physician at Anesthesiology Department
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Coronavirus Infections