Clinical trial NCT05731570: Cognitive Rehabilitation for People With Cognitive Covid19
Official title: Cognitive Impairment in Long Covid: PhEnotyping and RehabilitatiOn (CICERO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long Covid19
Keywords: cognitive rehabilitation
brain fog
Covid19
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Bangor University
name: St George's University Hospitals NHS Foundation Trust
name: University of Brighton
name: University Hospital Southampton NHS Foundation Trust
name: Greater Manchester Mental Health NHS Foundation Trust
First posted: 2023-02-16
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work.

This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available "Covid-19 Cognitive Recovery Guide" for affected people, their close contacts and clinicians.

In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.


Eligibility criteria: Inclusion Criteria:

1. Aged between 30 and 60 years
2. Evidence of prior CV19 infection:

   * either positive CV19 PCR
   * or positive CV19 antibody test
   * or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid
3. Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection

Exclusion Criteria:

1. Cognitive impairment prior to CV19 infection
2. Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae
3. People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition
4. A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition
5. High alcohol intake
6. Recreational drug use
7. Loss of mental capacity such that the affected individual is unable to give informed consent
8. Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation.
9. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.

Primary outcomes:
measure: Change in Goal-attainment
timeFrame: measured at baseline, 3 and 6 months post-randomisation
Secondary outcomes:
measure: Change in cognitive function
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in quality of life (EQ-5D-5L)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Life Space Questionnaire
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Social Functioning (SF-DEM)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Instrumental Activities of Daily Living (IADL) Scale
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Patient Health Questionnaire (PHQ-8)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Chalder Fatigue Scale
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Pittsburgh Sleep Quality (PSQI)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).
timeFrame: measured at baseline, 3 and 6 months post-randomisation
measure: Change in Client Service Receipt Inventory (CSRI)
timeFrame: measured at baseline, 3 and 6 months post-randomisation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Dennis Chan, Dr
role: PRINCIPAL_INVESTIGATOR
References: