Muscle Mass and Strength as Predictors of Time to Discharge in Patients With COVID-19

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT04406233
Collaborator
(none)
176
1
24
7.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    176 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    May 23, 2020
    Anticipated Primary Completion Date :
    May 23, 2022
    Anticipated Study Completion Date :
    May 23, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Time to medical discharge [through the hospitalization period, an average of 15 days]

      Length (in days) of the time hospitalization until medical discharge

    Secondary Outcome Measures

    1. All-cause mortality [through the hospitalization period, an average of 15 days, 60, 180 and 360 days after medical discharge]

      All-cause mortality rate along the study

    2. Hospital readmission [60, 180 and 360 days after medical discharge]

      Occurrence of medical complications that require hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 Years and older ;

    • hospital stay less than 48 hours;

    • length of hospital stay to 48 hours no requiring invasive mechanical ventilation;

    Exclusion Criteria:
    • cancer in the last 5 years;

    • delirium;

    • cognitive deficit that impossibility the patient to read and sign the informed consent form;

    • neurological disease;

    • degenerative muscular disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univsersity of Sao Paulo Sao Paulo Brazil 05508-030

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruno Gualano, Phd, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT04406233
    Other Study ID Numbers:
    • 31303720.7.0000.0068
    First Posted:
    May 28, 2020
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 28, 2020