RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on… (NCT05965752) | Clinical Trial Compass
CompletedNot Applicable
RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms
United States328 participantsStarted 2023-09-01
Plain-language summary
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 years of age at the time of enrollment
✓. PROMIS-Cog T-score \< 40
✓. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization
✓. Cognitive dysfunction symptoms following a SARS-CoV-2 infection that have persisted for at least 12 weeks and are still present at the time of consent
✓. Fluent in English or Spanish language
✓. Willing and able to provide informed consent, complete the intervention, complete the intervention assessments, and return for all of the necessary follow-up visits
Exclusion criteria
✕. Prior or active unstable or progressive major psychiatric or neurologic condition that would not show improvement and could hide treatment effect and is not related to SARS-CoV-2 infection, at the investigator's discretion, including, but not limited to, the following examples:
✕. Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not related to SARS-CoV-2 infection
What they're measuring
1
Total Number of Participants Enrolled in Each Appendix
✕. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
✕. Current use of symptomatic therapies including prescribed or illicit stimulants, amantadine, N-methyl-D-aspartate receptor antagonists (e.g., memantine, dissociative drugs)
✕. Current use of a stimulant for treating any PASC-related symptom
✕. Current diagnosis of alcohol and substance use disorders
✕. Insufficient visual, auditory, and motor function to participate in intervention and assessments