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NCT Number: NCT06992414

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

8 g/day creatine monohydrate powder

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Fatigue

    Time frame: 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

  2. Brain fog

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Keely A Shaw, PhD

CONTACT

[email protected]

3064587102

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 31, 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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