Journal article
Longitudinal Patient-Reported Outcome Trajectories in Long COVID: Findings From the STOP-PASC Clinical Trial
Open forum infectious diseases, Vol.12(10), p.ofaf634
10/01/2025
DOI: 10.1093/ofid/ofaf634
PMID: 41164784
Abstract
Background Long COVID is a heterogeneous post-infectious condition. Although patient-reported outcome (PRO) measures for diagnosis or therapeutic monitoring have been adapted from related complex chronic illnesses, no PRO has been validated specifically in Long COVID. The STOP-PASC randomized, placebo-controlled trial of nirmatrelvir/ritonavir (NMV/r) in adults with Long COVID showed no overall treatment effect. This exploratory analysis aimed to identify distinct symptom trajectories and clinical characteristics associated with improvement or worsening over time.Methods We performed latent class trajectory modeling (LCTM) on PRO measures-including the Patient Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), PROMIS domains, and core symptoms-among 155 randomized participants. Participants were followed for 15 weeks with serial symptom assessments. Trajectory groups were identified using Bayesian Information Criteria and characterized using descriptive statistics and absolute standardized differences.Results LCTM revealed heterogeneity in symptom trajectories. Two groups emerged for PGIS (improving n = 17, persistent/severe n = 136) and PGIC (improving n = 130; worsening n = 22). PROMIS-Physical Function modeling identified four groups (improving, normal/mild, moderate, and severe), fatigue core symptom modeling identified three (improving; moderate; severe). Worsening groups had higher proportions of NMV/r-treated participants and greater prevalence of cardiovascular symptoms and low-dose naltrexone use. Improving groups had shorter time since infection and higher baseline physical function. No subgroup showed a clear benefit from NMV/r.Conclusions Distinct PRO trajectories reflect the clinical heterogeneity of Long COVID. NMV/r showed no clear benefit across subgroups. These findings emphasize the need for validated, Long COVID-specific PRO instruments and targeted therapeutic trials tailored to Long COVID subtypes.
Details
- Title: Subtitle
- Longitudinal Patient-Reported Outcome Trajectories in Long COVID: Findings From the STOP-PASC Clinical Trial
- Creators
- Prasanna Jagannathan - Stanford UniversityHaley Hedlin - Stanford UniversityJane W. Liang - Kaiser PermanenteBlake Shaw - Stanford UniversityEvan Maestri - Stanford MedicineMichelle Lin - Stanford UniversityP. J. Utz - Stanford MedicineUpinder Singh - University of IowaLinda N. Geng - Stanford UniversityHector Bonilla - Stanford Medicine
- Resource Type
- Journal article
- Publication Details
- Open forum infectious diseases, Vol.12(10), p.ofaf634
- DOI
- 10.1093/ofid/ofaf634
- PMID
- 41164784
- ISSN
- 2328-8957
- eISSN
- 2328-8957
- Publisher
- Oxford Univ Press
- Number of pages
- 8
- Grant note
- National Center for Research Resources; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) Stanford School of Medicine Research Office UL1 TR001085 / National Center for Advancing Translational Sciences, National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) Pfizer, Inc.; Pfizer UL1 TR003142 / National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA 5UL1TR003142 / Stanford CTSA Award from the National Center for Advancing Translational Science (NCATS), a component of the National Institutes of Health (NIH-NCATS-CTSA)
- Language
- English
- Date published
- 10/01/2025
- Academic Unit
- Internal Medicine
- Record Identifier
- 9985244659102771
Metrics
1 Record Views