Muscle Mass & Strength as Predictors of Time to Discharge in Patients With

Status Recruiting

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

Clinical Trial 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

Related Conditions & MeSH terms

SARS-CoV 2

Clinical Trial Details

NCT number	NCT04406233
Study type	Observational
Source	University of Sao Paulo
Contact
Status	Recruiting
Phase
Start date	May 23, 2020
Completion date	May 23, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms