<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/NCT04406233</url>
  </required_header>
  <id_info>
    <org_study_id>31303720.7.0000.0068</org_study_id>
    <nct_id>NCT04406233</nct_id>
  </id_info>
  <brief_title>Muscle Mass and Strength as Predictors of Time to Discharge in Patients With COVID-19</brief_title>
  <official_title>Muscle Mass and Strength as Predictors of Time to Medical Discharge and Mortality in Patients Hospitalized With COVID-19: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The severe acute respiratory syndrome induced by the new coronavirus (SARS-CoV-2) has been&#xD;
      declared a worldwide pandemic. Identifying common characteristics of the disease is crucial&#xD;
      to promote a better prognosis for patients and to reduce the occurrence of medical&#xD;
      complications, the time to medical discharge and mortality rates. Muscle mass and strength&#xD;
      are recognized predictive measures of medical complications and mortality in different&#xD;
      populations, but it is still unclear whether these also applies to patients with SARS-CoV-2.&#xD;
      Therefore, this study will investigate whether muscle mass and/or muscle strength are&#xD;
      predictors of the time until medical discharge of patients hospitalized with SARS-CoV-2. Our&#xD;
      working hypothesis is that muscle mass and/or muscle strength are predictive measurements of&#xD;
      the time until medical discharge of patients hospitalized with SARS-CoV-2&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle mass (via ultrasound) and muscle strength (via handgrip) of patients with SARS-CoV-2&#xD;
      will be assessed upon admission, medical discharge and 180 days after medical discharge. The&#xD;
      time until medical discharge and any medical complications will be recorded. Throughout the&#xD;
      hospitalization period, the mortality rate will also be assessed. One hundred and eighty days&#xD;
      after medical discharge, the number of hospital readmissions, mortality rate and the use of&#xD;
      public health services will be evaluated, to estimate the cost of each patient to the health&#xD;
      service. Patients will be stratified according to muscle mass and strength assessed at&#xD;
      admission. Data will be analysed using a mixed model with repeated measures assuming group&#xD;
      (percentiles) and time (admission, medical discharge, and 180 days after medical discharge)&#xD;
      for each dependent variable. In the event of a significant F-value, Tukey-Kramer post hoc&#xD;
      adjustments will be used for multiple purposes. Survival rate will be examined using the&#xD;
      Kaplan-Meier curve and analyzed using the Log-rank test (Mantel-Cox). The level of&#xD;
      significance will be set apriori at P≤0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Anticipated">May 23, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 23, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to medical discharge</measure>
    <time_frame>through the hospitalization period, an average of 15 days</time_frame>
    <description>Length (in days) of the time hospitalization until medical discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>through the hospitalization period, an average of 15 days, 60, 180 and 360 days after medical discharge</time_frame>
    <description>All-cause mortality rate along the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>60, 180 and 360 days after medical discharge</time_frame>
    <description>Occurrence of medical complications that require hospitalization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">176</enrollment>
  <condition>SARS-CoV 2</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with SARS-CoV-2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 Years and older ;&#xD;
&#xD;
          -  hospital stay less than 48 hours;&#xD;
&#xD;
          -  length of hospital stay to 48 hours no requiring invasive mechanical ventilation;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cancer in the last 5 years;&#xD;
&#xD;
          -  delirium;&#xD;
&#xD;
          -  cognitive deficit that impossibility the patient to read and sign the informed consent&#xD;
             form;&#xD;
&#xD;
          -  neurological disease;&#xD;
&#xD;
          -  degenerative muscular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Univsersity of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Gualano, Phd</last_name>
      <phone>551130918783</phone>
      <email>gualano@usp.br</email>
    </contact>
    <investigator>
      <last_name>Bruno Gualano, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Gualano</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <!-- 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/NCT04406233
org study id: 31303720.7.0000.0068
nct id: NCT04406233
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The severe acute respiratory syndrome induced by the new coronavirus (SARS-CoV-2) has been
      declared a worldwide pandemic. Identifying common characteristics of the disease is crucial
      to promote a better prognosis for patients and to reduce the occurrence of medical
      complications, the time to medical discharge and mortality rates. Muscle mass and strength
      are recognized predictive measures of medical complications and mortality in different
      populations, but it is still unclear whether these also applies to patients with SARS-CoV-2.
      Therefore, this study will investigate whether muscle mass and/or muscle strength are
      predictors of the time until medical discharge of patients hospitalized with SARS-CoV-2. Our
      working hypothesis is that muscle mass and/or muscle strength are predictive measurements of
      the time until medical discharge of patients hospitalized with SARS-CoV-2
Muscle mass (via ultrasound) and muscle strength (via handgrip) of patients with SARS-CoV-2
      will be assessed upon admission, medical discharge and 180 days after medical discharge. The
      time until medical discharge and any medical complications will be recorded. Throughout the
      hospitalization period, the mortality rate will also be assessed. One hundred and eighty days
      after medical discharge, the number of hospital readmissions, mortality rate and the use of
      public health services will be evaluated, to estimate the cost of each patient to the health
      service. Patients will be stratified according to muscle mass and strength assessed at
      admission. Data will be analysed using a mixed model with repeated measures assuming group
      (percentiles) and time (admission, medical discharge, and 180 days after medical discharge)
      for each dependent variable. In the event of a significant F-value, Tukey-Kramer post hoc
      adjustments will be used for multiple purposes. Survival rate will be examined using the
      Kaplan-Meier curve and analyzed using the Log-rank test (Mantel-Cox). The level of
      significance will be set apriori at P≤0.05.
observational model: Cohort
time perspective: Prospective
measure: Time to medical discharge
time frame: through the hospitalization period, an average of 15 days
description: Length (in days) of the time hospitalization until medical discharge
measure: All-cause mortality
time frame: through the hospitalization period, an average of 15 days, 60, 180 and 360 days after medical discharge
description: All-cause mortality rate along the study
measure: Hospital readmission
time frame: 60, 180 and 360 days after medical discharge
description: Occurrence of medical complications that require hospitalization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Gualano
investigator title: Phd