Addressing Cognitive Fog in Long-COVID-19 Patients

Cognitive Impairment Clinical Trial

Official title:

Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05597722
• Other study ID #: STUDY22050191
• Status: Terminated
• Phase: Phase 4
• Start date: April 4, 2023
• Est. completion date: May 18, 2023

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible participants will be randomized to one of two arms. One intervention targets cognitive fog associated with depression (RxWell mobile app), the other the cognitive fog directly (Amphetamine-dextroamphetamine medication). Two weeks after randomization, participants are contacted by study staff to complete the GAD7. Participants who are randomized to RxWell will be offered assistance if they were not able to download the app on their own. Participants who are randomized to receive the stimulant will also complete a stimulant drug side effect rating scale to determine if the participant has any effects from the medication.

All participants will complete computerized neurocognitive assessments (ImPACT, and BrainCheck) and other study measures (MOCA (Screen, 1.5 and 3 months), Patient Health Questionnaire, Generalized Anxiety Disorder Measure, Satisfaction with Life Scale, PCL-5 Post Traumatic Stress Disorder checklist, ADHD Symptom Screener, and Sheehan Disability Scale) at baseline, 1.5 (interim) and 3 months after randomization. The study measures, other than the neuro-cognitive assessments, will be completed via REDCap.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• History of SARS-CoV-2 infection as defined as a positive PCR or home antigen test

• Patients with Long-COVID as defined as COVID symptoms that persist for three months or longer.

• Between the ages of 21 and 65

• Moderate cognitive impairment (MOCA score to meet criteria is < or =18) present for at least 3 months

• Response of "No" to the screening question, "Are you pregnant or do you plan to become pregnant in the next 3 months?"

• Access to a smartphone

Exclusion Criteria:

• History of dementia, psychosis, mania, addiction or current conditions requiring immediate hospitalization

• Previous adverse or allergic reaction to Adderall or other amphetamines

• Pre-existing cardiac or kidney condition, severe hypertension, glaucoma, advanced arteriosclerosis, hyperthyroidism, and taking an MAOI within the past 14 days

• Current or past substance misuse

• Previous use of RxWell (completed 3 or more techniques)

• Current use of amphetamine-dextroamphetamine

• History of uncontrolled blood pressure

• Subjects 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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Long COVID

Intervention

Behavioral:
• Digital cognitive behavioral intervention-RxWell
RxWell is a coach enhanced digital behavioral health intervention that teaches techniques to help manage emotional distress, which may improve cognitive fog and/or depression. Participants will have access to this app for three months.

Drug:
• Amphetamine-Dextroamphetamine
Participants randomized to this arm will be prescribed 10mg of amphetamine-dextroamphetamine to take as needed to help with cognitive fog. Participants in this arm will be contacted at 2 and 6 weeks to assess for any side effects from taking the medication.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eva Szigethy	The Beckwith Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Impairment - MOCA	The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.	Compare baseline to 12 weeks
Primary	Change in Cognitive Impairment - BrainCheck	BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.	Compare baseline to 12 weeks
Primary	Change in Cognitive Impairment - ImPACT	ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.	Compare baseline to 12 weeks
Secondary	Change in Depression - PHQ8	Patient Health Questionnaire (PHQ8) will be utilized to measure change in depression severity from baseline up to 12 weeks after baseline.; The PHQ-8 is an 8 item questionnaire. Scores can range from 0-24. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-24 indicates severe depressive symptoms.	Compare baseline up to 12 weeks
Secondary	Change in Quality of Life - SWLS	Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline.; SWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.	Compare baseline up to 12 weeks
Secondary	Change in Disability	Sheehan Disability Scale assess functional impairment in three inter-related domains; work/school, social and family life. The three items are summed into a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).	Compare baseline up to 12 weeks