Long COVID FatigueNCT06992414
Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19
A study testing Creatine monohydrate in people with Long COVID Fatigue, run by University of Calgary.
Trial summary
Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID Fatigue
- What is being tested?
- Creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing symptoms at least 3 months after a COVID-19 diagnosis confirmed by positive polymerase chain reaction (PCR) test
- Experiencing post-exertional malaise, as per the DePaul Symptom Questionnaire
Who cannot join
- Allergy or intolerance to creatine monohydrate or maltodextrin
- Supplemented with creatine in the past eight weeks
- orthopaedic injury or condition that would prevent exercise testing
- change in medication related to Long COVID symptom management in the past month.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial
Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM
Read the detailed description
cognitive dysfunction, and post-exertional malaise are common complaints of those living with Post-COVID Condition (PCC), a sequelae of symptoms that persist beyond acute infection. Similar to other types of post-viral fatigue, the diagnosis and treatment of PCC are challenging due to the lack of a valid biomarker for the condition. Though the etiology of PCC is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with PCC, which may contribute to fatigue. The objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and PEM in individuals living with PCC.
Participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. Venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. During the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). Cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.
- Conditions
- Long COVID Fatigue
- Being tested
- Creatine monohydrate
- Keywords
- creatine, post-exertional malaise, exercise, nutraceutical
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDietary supplement
8 g/day creatine monohydrate powder
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Experimental | 8 g/day creatine monohydrate Receives: Dietary Supplement: Creatine monohydrate |
| Maltodextrin | Placebo comparator | 8 g/day maltodextrin Receives: Dietary Supplement: Creatine monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption at ventilatory threshold
point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption
Measured: From enrollment to the end of intervention at 8 weeks
Heart rate at ventilatory threshold
heart rate (in bpm) at point of ventilatory threshold
Measured: From enrollment to the end of intervention at 8 weeks
Secondary outcomes (2)
Fatigue
severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable
Measured: From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)
Brain fog
severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable
Measured: From baseline to mid intervention (4 weeks) to post intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start2 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID FatigueStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to the treatment or control group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keely Shaw, University of Calgary
- Investigators
- Keely A Shaw, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992414
- Sponsor's protocol ID
- REB25-0930
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be provided upon reasonable request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06992414
- Acronym / sponsor ID
- REB25-0930
- Conditions
- Long COVID Fatigue
- Keywords
- creatine, post-exertional malaise, exercise, nutraceutical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 2 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 May 2025 (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.
Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM
Detailed description
cognitive dysfunction, and post-exertional malaise are common complaints of those living with Post-COVID Condition (PCC), a sequelae of symptoms that persist beyond acute infection. Similar to other types of post-viral fatigue, the diagnosis and treatment of PCC are challenging due to the lack of a valid biomarker for the condition. Though the etiology of PCC is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with PCC, which may contribute to fatigue. The objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and PEM in individuals living with PCC.
Participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. Venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. During the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). Cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to the treatment or control group
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate | Experimental | Dietary Supplement: Creatine monohydrate8 g/day creatine monohydrate |
| Maltodextrin | Placebo comparator | Dietary Supplement: Creatine monohydrate8 g/day maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Experiencing symptoms at least 3 months after a COVID-19 diagnosis confirmed by positive polymerase chain reaction (PCR) test
- Experiencing post-exertional malaise, as per the DePaul Symptom Questionnaire
Key exclusion criteria (4 listed)
- Allergy or intolerance to creatine monohydrate or maltodextrin
- Supplemented with creatine in the past eight weeks
- orthopaedic injury or condition that would prevent exercise testing
- change in medication related to Long COVID symptom management in the past month.
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 |
|---|---|---|
| Creatine monohydrate8 g/day creatine monohydrate powder | Dietary supplement | Creatine monohydrate, Maltodextrin |
Primary outcome
Oxygen consumption at ventilatory threshold
Time frame: From enrollment to the end of intervention at 8 weeks
point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption
Heart rate at ventilatory threshold
Time frame: From enrollment to the end of intervention at 8 weeks
heart rate (in bpm) at point of ventilatory threshold
2 secondary outcomes
Fatigue
Time frame: From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)
Brain fog
Time frame: From baseline to mid intervention (4 weeks) to post intervention (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes. IPD will be provided upon reasonable request to the PI
Related trials for Long COVID Fatigue
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
RecruitingPhase 2
LIFT: Life Improvement Trial
ME/CFS, Long COVID
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.
Keely A Shaw, PhD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Long COVID Fatigue, run by University of Calgary.
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 4 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: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keely A Shaw, PhD (3064587102, keely.shaw@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption at ventilatory threshold (time frame: From enrollment to the end of intervention at 8 weeks). 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?
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 31 May 2025.