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

Korábbi kezelés

• 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:
  • Progressive neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, etc.
  • 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.
  • 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
• Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not related to SARS-CoV-2 infection
• Current use of symptomatic therapies including prescribed or illicit stimulants, amantadine, N-methyl-D-aspartate receptor antagonists (e.g., memantine, dissociative drugs)
• Current diagnosis of alcohol and substance use disorders
  • Prior use disorders acceptable if abstinence achieved and maintained for at least 12 months before study enrollment
• Currently receiving/using intervention from another clinical trial, such as another RECOVER trial

Más betegség

• Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
• Known allergy/sensitivity/hypersensitivity to components of the intervention or comparator\*
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • 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.

Egyéb

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Current use of a stimulant for treating any PASC-related symptom
• Insufficient visual, auditory, and motor function to participate in intervention and assessments
• Known pregnancy
• Current or recent use (within the last 2 months) of intervention\*

• In order to be eligible to participate in this study, an individual must meet all of the following 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
  • Suspected case of SARS-CoV-2 infection - three options, A through C:
  • Met clinical OR epidemiological criteria:
  • Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia; b. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster;
  • Presented acute respiratory infection with history of fever or measured fever of ≥ 38°C and cough, with onset within the last 10 days, and who requires hospitalization; or
  • Presented with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
  • Probable case of SARS-CoV-2 infection, defined as having met clinical criteria above AND was a contact of a probable or confirmed case or was linked to a COVID-19 cluster.
  • Confirmed case of SARS-CoV-2 infection - two options, A through B:
  • Presented with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or
  • Met clinical AND/OR epidemiological criteria (See suspected case A.a.), with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
  • \* Suspected and probable cases will only be allowed if they occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
• 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