Addressing Cognitive Fog in Long-COVID-19 Patients

NCT05597722 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY22050191
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment; Long COVID

Keywords

Cognitive fog, Long-COVID

Outcome Measures

Primary Outcomes (3)

• 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

• Change in Cognitive Impairment - BrainCheck

  BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.

  Compare baseline to 12 weeks

• 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 Outcomes (3)

• Change in Depression - PHQ8

  Compare baseline up to 12 weeks

• Change in Quality of Life - SWLS

  Compare baseline up to 12 weeks

• Change in Disability

  Compare baseline up to 12 weeks

Study Arms (2)

Digital cognitive behavioral intervention- RxWell

ACTIVE COMPARATOR

The mobile app provides users with brief skill building techniques such as relaxation, behavioral activation and exposure, distress tolerance, cognitive reframing, and mindfulness meditation, for anxiety and depression. The content of RxWell was developed based on standard CBT techniques for treating anxiety disorders and depression. The user will have the option to select either the depression or anxiety program, and the coach will have the ability to personalize the program so that the individual can utilize the proper CBT techniques that fits with their presentation. The health coach communicates with RxWell users via asynchronous, secure within app messaging. They reinforce CBT principles, guide users through goal setting, and help users work through challenges and recognize successes. The coaches will also receive individualized cognitive rehabilitation tips from the speech therapist after their appointment with the participant.

Behavioral: Digital cognitive behavioral intervention-RxWell

Stimulant Medication

ACTIVE COMPARATOR

The other intervention is a stimulant medication known to reduce cognitive impairment in other chronic medical conditions, such as Inflammatory Bowel Disease. The Long-COVID psychiatrist will order the medication and the participant will be scheduled for a 6-week research tele visit with the psychiatrist to monitor for any medication side effects. Amphetamine-dextroamphetamine drug dose will be 10mg daily for 12 weeks, and no dose changes will be made. Amphetamine-dextroamphetamine is a Schedule II controlled substance that has a risk for abuse, tolerance, and psychological dependence, which can be associated with severe social disability.

Drug: Amphetamine-Dextroamphetamine

Interventions

Digital cognitive behavioral intervention-RxWell BEHAVIORAL

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.

Digital cognitive behavioral intervention- RxWell

Amphetamine-Dextroamphetamine DRUG

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.

Also known as: Adderall

Stimulant Medication

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eva Szigethy: lead
• The Beckwith Institute: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Post-Acute COVID-19 Syndrome

Interventions

SLI381; Adderall

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eva Szigethy
• Organization: University of Pittsburgh

szigethye@upmc.edu

412-667-0416

Study Officials

• Eva Szigethy, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry Pediatrics and Medicine

Model Details: This is a randomized 1:1 block design trial evaluating the effect of a digital cognitive behavioral app versus a drug therapy (amphetamine-dextroamphetamine \[Adderall\]) on cognitive impairment and other secondary outcomes in subjects with post-COVID symptoms (Long-COVID). The participants will be stratified by depression severity.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: October 28, 2022
• Study Start: April 4, 2023
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)