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NCT05597722
Addressing Cognitive Fog in Long-COVID-19 Patients
Conditions: Cognitive Impairment, Long COVID
Sex: All
Ages: 21 Years – 65 Years
Phase: PHASE4
Enrollment: 120
Sponsor: Eva Szigethy
Location: United States
Summary
This study will assess two options to help patients better manage the cognitive fog and emotional distress that may be associated with having Long-COVID.
Long-COVID is post-COVID conditions or symptoms lasting more than four weeks after infection.
Clinicians from the UPMC Long-COVID Clinic leading this study are evaluating the utility of computer-based evaluation of COVID-related cognitive fog and the helpfulness of two intervention strategies to treat moderate cognitive impairment using a randomized trial.
The two intervention strategies include 1) a standardized dosing of amphetamine/dextroamphetamine medication that has been used to improve cognitive fog; and 2) a digital behavioral tool with an embedded health coach that is used on a mobile phone.
Eligibility Criteria
Inclusion Criteria:History of SARS-CoV-2 infection as defined as a positive PCR or home antigen testPatients with Long-COVID as defined as COVID symptoms that persist for three months or longer.Between the ages of 21 and 65Moderate cognitive impairment (MOCA score to meet criteria is < or =18) present for at least 3 monthsResponse of "No" to the screening question, "Are you pregnant or do you plan to become pregnant in the next 3 months?"Access to a smartphoneExclusion Criteria:History of dementia, psychosis, mania, addiction or current conditions requiring immediate hospitalizationPrevious adverse or allergic reaction to Adderall or other amphetaminesPre-existing cardiac or kidney condition, severe hypertension, glaucoma, advanced arteriosclerosis, hyperthyroidism, and taking an MAOI within the past 14 daysCurrent or past substance misusePrevious use of RxWell (completed 3 or more techniques)Current use of amphetamine-dextroamphetamineHistory of uncontrolled blood pressureSubjects taking Methylphenidate; Lisdexamfetamine; non-Adderall amphetamine products; Atomoxetine; Viloxazine; Modafinil; Armodafinil; Nortriptyline and other tricyclic drugs; Bupropion; Tramadol; and Monoamine Oxidase Inhibitor (MAOI) drugs (including Linezolid).Inability to pay for study medication.
Source: ClinicalTrials.gov (NCT05597722). StuddyBuddy aggregates publicly available trial information.