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

SARS-CoV 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406233
• Other study ID #: 31303720.7.0000.0068
• Status: Recruiting
• Start date: May 23, 2020
• Est. completion date: May 23, 2022

Study information

• Verified date: May 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV 2

Locations

Country	Name	City	State
Brazil	Univsersity of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to medical discharge	Length (in days) of the time hospitalization until medical discharge	through the hospitalization period, an average of 15 days
Secondary	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
Secondary	Hospital readmission	Occurrence of medical complications that require hospitalization	60, 180 and 360 days after medical discharge