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Active, Not Recruiting

NCT Number: NCT04849624

Body Composition Study in Critically Ill Patients-Extended to COVID-19

Muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between COVID-19 and non COVID-19 critically ill patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Critical Illness Atrophy COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Disease Attributes Infections Lung Diseases Muscle Atrophy Muscle Strength Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

Given the heightened inflammatory status among COVID-19 critically ill patients, we hypothesized that the rate of skeletal muscle loss is accelerated in this population, and this loss is even more pronounce than the general critically ill patients. We further hypothesized that the increased muscle loss will lead to worse functional outcome (lower muscle strength) in COVID-19 critically ill patients compared with age- and sex-matched non-COVID-19 critically ill patients, as it has been shown that quadriceps thickness is strongly correlated with functional status at ICU discharge. Furthermore, a recent systematic review and meta-analysis in survivors of coronavirus (severe acute respiratory syndrome, SARS or Middle-east respiratory syndrome, MERS, or COVID-19) also demonstrated reduced exercise capacity and quality of life at 6 months after hospitalization or ICU admission

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • Admitted into the ICU due to COVID-19

Exclusion criteria

  • Likely to transfer out from the ICU in 24 hours from screening
  • Likely to die in the next 7 days
  • Bedbound prior to hospital admission or bedbound in the hospital for >10 days

Treatment and study plan

No intervention

Other

This is an observational study and involved no intervention

Primary outcomes

  1. Rectus Femoris Thickness

    Time frame: Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

    Change in Rectus Femoris Thickness

  2. Rectus Femoris Cross-sectional Area

    Time frame: Change in Rectus Femoris Cross-sectional Area at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

    Change in Rectus Femoris Cross-sectional Area

Secondary outcomes

  1. Forearm Muscle Thickness

    Time frame: Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)

    Change in Forearm Muscle Thickness

  2. Handgrip Strength

    Time frame: Before Hospital Discharge

    BIlateral Handgrip Strength

  3. Knee Extension Strength

    Time frame: Before Hospital Discharge

    BIlateral Knee Extension Strength

Other outcomes

  1. Mortality

    Time frame: Mortality at day 28 (calculated from the first day of ICU admission)

    28-day Mortality

  2. ICU length of stay

    Time frame: From date of enrolment until the date of discharged from the ICU, assessed up to 60 days

    Length of stay in the ICU

  3. Hospital length of stay

    Time frame: From date of enrolment until the date of discharged from the hospital, assessed up to 60 days

    Length of stay in the Hospital

  4. Length of Mechanical Ventilation

    Time frame: From date of commencement of mechanical ventilation until the date of liberation from mechanical ventilation, assessed up to 60 days

    Duration of Mechanical Ventilation

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Acronym: COVID-MUSCLE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 19, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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