Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19

Not Applicable

Not yet recruiting

• Conditions: Long COVID Fatigue

• Registration Number: NCT06992414
• Lead Sponsor: University of Calgary

Brief 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

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-31
• Study Start: 2025-07-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygen consumption at ventilatory threshold	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	From enrollment to the end of intervention at 8 weeks	heart rate (in bpm) at point of ventilatory threshold

Secondary Outcome Measures

Name	Time	Method
Fatigue	From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)	severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable
Brain fog	From baseline to mid intervention (4 weeks) to post intervention (8 weeks)	severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable