Dolphin
Senior Member (Voting Rights)
[At least some of these are patients]
Sec. Infectious Diseases: Epidemiology and Prevention
Volume 14 - 2026 | https://doi.org/10.3389/fpubh.2026.1972605
Femke C. C. van Rhijn-Brouwer 1*, Chloé de Canson 2,
Joanneke E. L. VanDerNagel 3, Xandra Westerhuis 4,
Susanne Y. Young 5, Sander M. J. van Kuijk 6, Laura V. de Vries 7,
Jon-Ruben van Rhijn 8 and Merel Hellemons 9
Long COVID is a multisystem disease that affects approximately 10% of people after a SARS-CoV-2 infection.
In the absence of curative treatment, high-quality clinical treatment trials are urgently needed for long COVID.
There is significant overlap between long COVID and other infection-associated chronic conditions, in particular myalgic encephalomyelitis.
As such, trial design for long COVID can benefit from prior experience in this field.
In this review we explore outcome measures in long COVID and myalgic encephalomyelitis clinical trials to survey current practices, and provide recommendations for future clinical trials.
PubMed and Clinicaltrials.gov were searched for clinical trials on long COVID and myalgic encephalomyelitis that featured a biomedical intervention.
37 myalgic encephalomyelitis and 68 long COVID trials were identified that used 397 outcome measures in total. We then critically assessed the relevance of these outcome measures for patients.
Conclusion:
Long COVID trial design could be improved by incorporating outcomes that address important symptom clusters such as post-exertional malaise, dysautonomia and mast cell activation.
Clinical assessments, physical tests and biomarkers can supplement patient reported outcome measure data, if safety, feasibility and applicability are carefully considered.
Lastly, safety of the intervention is rarely adequately evaluated.
We recommend a concerted effort to include patient input at all steps of clinical trial design, execution and evaluation.
REVIEW article
Front. Public Health, 19 October 2026Sec. Infectious Diseases: Epidemiology and Prevention
Volume 14 - 2026 | https://doi.org/10.3389/fpubh.2026.1972605
Outcome measures in long COVID clinical trials: a review
Femke C. C. van Rhijn-Brouwer 1*, Chloé de Canson 2,
Joanneke E. L. VanDerNagel 3, Xandra Westerhuis 4,
Susanne Y. Young 5, Sander M. J. van Kuijk 6, Laura V. de Vries 7,
Jon-Ruben van Rhijn 8 and Merel Hellemons 9
- 1. Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, Netherlands
- 2. Department of Theoretical Philosophy, University of Groningen, Groningen, Netherlands
- 3. Department of Human Media Interaction, University of Twente, Enschede, Netherlands
- 4. Research Physician, Amsterdam, Netherlands
- 5. Department of Primary and Community Care, Radboud University Medical Center, Nijmegen, Netherlands
- 6. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, Netherlands
- 7. Independent Researcher, Amsterdam, Netherlands
- 8. Institute for Life Sciences and Chemistry, HU University of Applied Sciences, Utrecht, Netherlands
- 9. Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, Netherlands
- View less
Abstract
Background:Long COVID is a multisystem disease that affects approximately 10% of people after a SARS-CoV-2 infection.
In the absence of curative treatment, high-quality clinical treatment trials are urgently needed for long COVID.
There is significant overlap between long COVID and other infection-associated chronic conditions, in particular myalgic encephalomyelitis.
As such, trial design for long COVID can benefit from prior experience in this field.
In this review we explore outcome measures in long COVID and myalgic encephalomyelitis clinical trials to survey current practices, and provide recommendations for future clinical trials.
PubMed and Clinicaltrials.gov were searched for clinical trials on long COVID and myalgic encephalomyelitis that featured a biomedical intervention.
37 myalgic encephalomyelitis and 68 long COVID trials were identified that used 397 outcome measures in total. We then critically assessed the relevance of these outcome measures for patients.
Conclusion:
Long COVID trial design could be improved by incorporating outcomes that address important symptom clusters such as post-exertional malaise, dysautonomia and mast cell activation.
Clinical assessments, physical tests and biomarkers can supplement patient reported outcome measure data, if safety, feasibility and applicability are carefully considered.
Lastly, safety of the intervention is rarely adequately evaluated.
We recommend a concerted effort to include patient input at all steps of clinical trial design, execution and evaluation.
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