Critical IllnessCOVID-MUSCLENCT04849624
Body Composition Study in Critically Ill Patients-Extended to COVID-19
An observational study of Critical Illness and Covid19, run by University of Malaya at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness, Covid19, Muscle Atrophy
- How many people
- 59 participants
- Where
- 1 siteMalaysia
- Study dates
- 5 Mar 2021to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 30 COVID-19 ICU patients as per the eligibility criteria will be recruited. A total of 20 non-COVID-19 ICU patients that are matched by age (+/- 10 years old), sex and ventilation mode (mostly will be with lung pathology) will be enrolled to compare their change in muscle mass and muscle strength at hospital discharge with COVID-19 ICU patients.
Who may be able to join
- ≥ 18 years old
- Admitted into the ICU due to COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
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.
Read the detailed description
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
- Conditions
- Critical Illness, Covid19, Muscle Atrophy, Muscle Strength
- Being tested
- No Intervention
- Medical subject headings
- Critical Illness, COVID-19, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observational study and involved no intervention
| Study group | Role | What they receive |
|---|---|---|
| ICU COVID-19 patients | COVID-19 patients that are admitted into the ICU and fulfilled the eligibility criteria Receives: Other: No Intervention | |
| ICU non-COVID-19 patients | Non-COVID-19 patients that are admitted into the ICU matched with ICU COVID-19 patients that are recruited and fulfilled the eligibility criteria Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus Femoris Thickness
Change in Rectus Femoris Thickness
Measured: Change in Rectus Femoris Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Rectus Femoris Cross-sectional Area
Change in Rectus Femoris Cross-sectional Area
Measured: Change in Rectus Femoris Cross-sectional Area at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Secondary outcomes (3)
Forearm Muscle Thickness
Change in Forearm Muscle Thickness
Measured: Change in Forearm Muscle Thickness at day 7 or ICU discharge or hospital discharge compared with baseline (Day 1 of ICU admission)
Handgrip Strength
BIlateral Handgrip Strength
Measured: Before Hospital Discharge
Knee Extension Strength
BIlateral Knee Extension Strength
Measured: Before Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start5 Mar 2021
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849624
- Sponsor's protocol ID
- 2019615-7520-3
- Acronym
- COVID-MUSCLE
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee ZY, Ong SP, Ng CC, Yap CSL, Engkasan JP, Barakatun-Nisak MY, Heyland DK, Hasan MS. Association between ultrasound quadriceps muscle status with premorbid functional status and 60-day mortality in mechanically ventilated critically ill patient: A single-center prospective observational study. Clin Nutr. 2021 Mar;40(3):1338-1347. doi: 10.1016/j.clnu.2020.08.022. Epub 2020 Aug 28.
PubMed 32919818
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Study in Critically Ill Patients-Extended to COVID-19
- ClinicalTrials.gov ID
- NCT04849624
- Acronym / sponsor ID
- COVID-MUSCLE / 2019615-7520-3
- Conditions
- Critical Illness, Covid19, Muscle Atrophy, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU COVID-19 patients | – | Other: No InterventionCOVID-19 patients that are admitted into the ICU and fulfilled the eligibility criteria |
| ICU non-COVID-19 patients | – | Other: No InterventionNon-COVID-19 patients that are admitted into the ICU matched with ICU COVID-19 patients that are recruited and fulfilled the eligibility criteria |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 COVID-19 ICU patients as per the eligibility criteria will be recruited. A total of 20 non-COVID-19 ICU patients that are matched by age (+/- 10 years old), sex and ventilation mode (mostly will be with lung pathology) will be enrolled to compare their change in muscle mass and muscle strength at hospital discharge with COVID-19 ICU patients.
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Admitted into the ICU due to COVID-19
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an observational study and involved no intervention | Other | ICU COVID-19 patients, ICU non-COVID-19 patients |
Primary outcome
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
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
3 secondary outcomes
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)
Handgrip Strength
Time frame: Before Hospital Discharge
Knee Extension Strength
Time frame: Before Hospital Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 32919818Lee ZY, Ong SP, Ng CC, Yap CSL, Engkasan JP, Barakatun-Nisak MY, Heyland DK, Hasan MS. Association between ultrasound quadriceps muscle status with premorbid functional status and 60-day mortality in mechanically ventilated critically ill patient: A single-center prospective observational study. Clin Nutr. 2021 Mar;40(3):1338-1347. doi: 10.1016/j.clnu.2020.08.022. Epub 2020 Aug 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Covid19, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.