Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06279936 |
| Other study ID # |
B3002021000171 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Universiteit Antwerpen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objectives:
To describe the standardized evaluation of the psychological and cognitive function of long
COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers
between long COVID patients and healthy controls, to explore cross-sectional and longitudinal
associations between immunological measures and long COVID symptoms.
Study design:
Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021
until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors
without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb).
The total sample size is estimated on 130. Four visits are organized: at baseline, three, six
and twelve months.
The study is organized in three work packages (WP). WP1 includes a blood withdrawal and
psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in
saliva and takes place on the baseline visit for every participant and on the third visit for
patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca
controls and on the third visit for patients.
Description:
Research Objectives
Describe the standardized evaluation of the psychopathological and neurocognitive function of
long COVID NP patients and their evolution over time; Compare the immunological profile and
the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19
survivors without persistent complaints and healthy uninfected controls; Explore the
cross-sectional and longitudinal association between long COVID NP symptoms and immunological
and cortisol measures.
Methodology
Recruitment and study population
Inclusion criteria - patients:
All patients 18-70 years referred to the University Psychiatric Hospital (Campus UZA and
Campus Duffel) for psychological and/or cognitive complaints at least >4 weeks following a
confirmed diagnosis of COVID-19 infection with a positive PCR test or an antibodies test will
be invited to participate in the study. The sample size of the patients is estimated on 50
participants. The patients have to be examined by their treating physician before enrollment
to make sure other medical causes for their complaints are excluded. A positive score on at
least two domains (psychological /cognitive) is necessary during the screening phase.
Inclusion criteria - controls:
Two control groups, one of 30 healthy uninfected controls (Cb), another of 50 COVID-19
survivors without persistent complaints (Ca), matched on age, sex and education with the
patient group will be included. The participants for Ca will be recruited in UZA and by
advertising. The healthy controls (Cb) will be recruited by mailing within the hospital and
by advertising. A positive score on maximum one domain (psychological / cognitive) is allowed
in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint
causes significant distress (which is investigated during the screening phase).
Exclusion criteria for each subgroup:
- HPA subgroup: Participant is pregnant or breastfeeding / Participant receives hormonal
replacement therapy (contraception is allowed) /Participant is treated with cortisol <4
weeks ago
- Neurocognitive assessment: IQ < 90 (screened with Raven Standard Progressive Matrices
(Short Form) (RSPM-SF) / Participant takes sedative medication: benzodiazepines (Larger
than the equivalent of diazepam 10mg per day, Last administration <8 hours prior to the
neurocognitive test), new sedative antipsychotics/antidepressants (<4 weeks), other
medication from DRUID class III (<4 weeks), last administration <8 hours prior to the
neurocognitive tests, or causing significant sedation / Severe substance abuse (alcohol
+ drugs) / Pre-existing neurological diseases causing cognitive problems.
Study design This is a longitudinal study, which will be organized into three work packages
(WP1, WP2 and WP3). Enrollment will continue for an estimated period of 24 months, depending
on the time course of the epidemic curve. Last-patient-in is expected no later than November
1st, 2023. Patients will be referred mainly by the University Hospital of Antwerp (UZA) and
enrolled at first visit to the University Psychiatric Hospital (UPCD), where follow-up will
also take place at 3, 6 and 12 months. Patients can also be referred by the Flemish long
COVID patient support group.
WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit.
WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every
participant and on the third visit for patients. Finally, WP3 includes a neurocognitive
assessment at baseline for patients and Ca controls and on the third visit for patients.
