NCT04406233

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 23, 2020

Last Update Submit

May 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to medical discharge

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

    through the hospitalization period, an average of 15 days

Secondary Outcomes (2)

  • All-cause mortality

    through the hospitalization period, an average of 15 days, 60, 180 and 360 days after medical discharge

  • Hospital readmission

    60, 180 and 360 days after medical discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with SARS-CoV-2

You may qualify if:

  • Years and older ;
  • hospital stay less than 48 hours;
  • length of hospital stay to 48 hours no requiring invasive mechanical ventilation;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 28, 2020

Study Start

May 23, 2020

Primary Completion

May 23, 2022

Study Completion

May 23, 2022

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations