RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •1. 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:
• •a. Progressive neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, etc.
• •b. Past traumatic brain injury occurrence still associated with active post-concussive symptoms c. Uncontrolled seizure disorder, such as having at least one seizure in the last year that is adjudicated by clinical judgement d. Post-stroke deficits that may interfere with assessment, such as language or communication difficulties, aphasia, etc.
• •e. Formal thought disorders, such as schizophrenia, etc. f. Any neuropsychiatric or neurologic disorder uncontrolled for the previous six months or that may interfere with assessment, at discretion of the investigator
• •2. Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not related to SARS-CoV-2 infection
• •3. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
• •4. Current use of symptomatic therapies including prescribed or illicit stimulants, amantadine, N-methyl-D-aspartate receptor antagonists (e.g., memantine, dissociative drugs)
• •5. Current use of a stimulant for treating any PASC-related symptom
• •6. Current diagnosis of alcohol and substance use disorders
• •a. Prior use disorders acceptable if abstinence achieved and maintained for at least 12 months before study enrollment
• •7. Insufficient visual, auditory, and motor function to participate in intervention and assessments
• •8. Known pregnancy
• •9. Current or recent use (within the last 2 months) of intervention\*
• •10. Known allergy/sensitivity/hypersensitivity to components of the intervention or comparator\*
• •11. Currently receiving/using intervention from another clinical trial, such as another RECOVER trial
• •12. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
• •1. The site investigator has the discretion to determine whether a participant is too cognitively impaired to participate and should instead be referred for clinical evaluation.
• •Exclusions specific to intervention appendices are listed in each appendix.
• •\* Relevant if only one intervention appendix is open at the time of enrollment, though exclusion may be qualified in the appendix. If multiple intervention appendices are open, a participant may be excluded from any intervention appendix based on contraindications listed in the intervention appendix, current use of intervention, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining intervention appendices.