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

Muscle Mass and Strength as Predictors of Time to Medical Discharge and Mortality in Patients Hospitalized With COVID-19: A Prospective Observational Study

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

Study Overview

• Status: Unknown
• Conditions: SARS-CoV 2

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 Type: Observational
• Enrollment (Anticipated): 176

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-030
    • Recruiting
    • Univsersity of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with SARS-CoV-2

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to medical discharge	Length (in days) of the time hospitalization until medical discharge	through the hospitalization period, an average of 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality rate along the study	through the hospitalization period, an average of 15 days, 60, 180 and 360 days after medical discharge
Hospital readmission	Occurrence of medical complications that require hospitalization	60, 180 and 360 days after medical discharge

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 23, 2020
• Primary Completion (ANTICIPATED): May 23, 2022
• Study Completion (ANTICIPATED): May 23, 2022

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 31303720.7.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No