NCT04772586

Brief Summary

The SarcoV study aims at assessing the association between sarcopenia and the indication of mechanical ventilation in older hospitalized patients due to COVID-19 infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

February 23, 2021

Last Update Submit

March 28, 2022

Conditions

Keywords

SarcopeniaMechanical ventilationOlder patientsCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Indication of mechanical ventilation

    Association between probable sarcopenia and the indication of mechanical ventilation in patients with COVID-19 infection. Mechanical ventilation was considered by non-invasive ventilation or invasive ventilation. For purpose of analysis, it was defined as a binary outcome (yes(no). Probable sarcopenia probable was defined according to the revised European consensus on definition and diagnosis of sarcopenia (EWGSOP2). For purpose of analysis, it was defined as a binary condition (yes/no).

    Through study completion, an average of 60 days

Secondary Outcomes (2)

  • Evaluate difficult-to-wean in mechanical ventilation

    Through study completion, an average of 60 days

  • All-cause mortality

    Through study completion, an average of 60 days

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 60 and older admitted in an acute care unit of Brugmann university hospital due to COVID-19

You may qualify if:

  • Consecutive patients aged 60 and older
  • Admission in an acute care unit in Brugmann university hospital due to a COVID-19 possible or confirmed infection. A infection was considered confirmed in presence of a positive molecular test by Polymerase-chain reaction (PCR), following the Belgian Public Health Department recommendations (Sciensano recommendations).

You may not qualify if:

  • Patients unable to perform a grip-strength measurement due to any rheumatological or neurological condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brugmann university hospital

Brussels, 1020, Belgium

Location

Related Publications (2)

  • Kou HW, Yeh CH, Tsai HI, Hsu CC, Hsieh YC, Chen WT, Cheng HT, Yu MC, Lee CW. Sarcopenia is an effective predictor of difficult-to-wean and mortality among critically ill surgical patients. PLoS One. 2019 Aug 8;14(8):e0220699. doi: 10.1371/journal.pone.0220699. eCollection 2019.

    PMID: 31393937BACKGROUND
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PMID: 31081853BACKGROUND

Related Links

MeSH Terms

Conditions

SarcopeniaCOVID-19

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr Murielle Surquin MD PhD

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

September 1, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations