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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05703074
Other study ID # 983971636
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 30, 2023
Est. completion date July 2025

Study information

Verified date May 2024
Source University Hospital, Akershus
Contact Vegard BB Wyller, PhD
Phone 91166681
Email v.b.b.wyller@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Long COVID, also referred to as post-acute sequela of COVID-19 (PASC), is present in a substantial number of individuals, and treatment for this is warranted. Two different hypothetical models of Long COVID suggest attenuated mitochondrial energy production and psychosocial load, respectively, to be key mechanisms in the underlying pathophysiology. Given the potential importance of metabolic disturbances, dietary supplement by Nicotinamide Riboside (NR, sales name Niagen®) may be beneficial. Given the potential importance of psychosocial factors, a tailored and personalized Mind-Body Reprocessing Therapy (MBRT) may be beneficial. The MBRT consists of 4 to 6 face-to-face therapist encounters in combination with digital resources. The primary objective is to determine whether NR 1000 mg twice daily and/or MBRT increase health-related quality of life in individuals with Long COVID compared with care as usual and/or placebo. The Medical Outcome Study 36-item short form (SF-36), general health subscore is the primary endpoint. Secondary endpoints are: Markers of inflammation (hsCRP) and cognitive function (digit span test), cost-effectiveness, and the patient-reported symptoms fatigue, dyspnoea, and global impression of change in symptoms, function and quality of life. Explorative objectives encompass intervention effects on additional cognitive function markers, biological markers (indices of autonomic nervous activity), disability markers (work attendance) and patient symptoms, as well as the exploration of long-term effects, differential subgroup effects, intervention effect mediators and intervention effect predictors. The study is a randomized controlled trial featuring a 2 x 2 factorial design where MBRT is compared with usual care and NR is compared with placebo. The latter comparison is double blinded. Eligible participants are individuals (18-70 years) with confirmed Long COVID interferring negatively with daily activities. A total of 310 participants will be enrolled. After baseline assessment (T1), the participants will be randomized 1:1 for both treatment comparisons, resulting in four treatment groups: a) MBRT and NR; b) usual care and NR; c) MBRT and placebo; d) usual care and placebo. All treatments last for three months, followed by primary endpoint assessment (T2). Total follow-up time is 12 months (T3). A comprehensive investigational program at all time points includes clinical examination, functional testing (spirometry, autonomic cardiovascular control, neurocognitive functions), sampling of biological specimens (blood) and questionnaire charting (background/demographics, clinical symptoms, psychosocial factors, study events).


Recruitment information / eligibility

Status Recruiting
Enrollment 310
Est. completion date July 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Undergone acute COVID-19, confirmed EITHER by a positive PCR-test OR a positive self-test combined with confirmatory antibody-pattern in blood. - Persistent symptoms at least 6 months following acute COVID-19 without symptom-free interval. - Functional disability to an extent that impacts negatively on normal activities (such as work attendance, physical exercise, social activities, etc.) - Informed consent Exclusion Criteria: - Other chronic illnesses, demanding life situations or concomitant drug use/substance abuse that is considered a plausible cause of persistent symptoms and associated disability - Sustained organ damage (lung, heart, brain) following acute, serious Covid-19 - Pregnancy. - Bedridden - Insufficient command of Norwegian

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nicotinamide Riboside (NR)
4 capsules (a total of 1000 mg) 2 times daily for 84 days
Behavioral:
Mind-body reprocessing therapy (MBRT)
4-6 face-to-face meetings over 3-4 weeks, unlimited access to designated online resources.
Care as usual
A brief self-help leaflet on long COVID is distributed, otherwise care as usual by the general practitioner
Dietary Supplement:
Placebo
4 capsules (empty) 2 times daily for 84 days.

Locations

Country Name City State
Norway Akershus University Hospital Lørenskog

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Attention bias A computerised test of attention bias towards illness-related words Three months after inclusion (T2)
Other Worrying tendencies Penn State Worry Questionnaire (PSWQ), total sum score (higher scores means more worrying) Three months after inclusion (T2)
Other Sympathetic predominance Heart rate variability (HRV) indices in the time and frequency domain using a 5-minute ECG recording obtained during supine rest Three months after inclusion (T2)
Other Post-exertional malaise (PEM) PEM items from the DePaul Symptom Questionnaire, total average score across five items Three months after inclusion (T2)
Other Pain Brief Pain Inventory (BPI), average score Three months after inclusion (T2)
Other Sleep difficulties Karolinska sleep questionnaire (KSQ), total sum score Three months after inclusion (T2)
Other Depression and anxiety Hospital Anxiety and Depression Symptoms (HADS), total sum score Three months after inclusion (T2)
Other Smell and taste Assessed by two singel questionnaire items; responses on a 5-point Likert scale Three months after inclusion (T2)
Other Executive functioning The trail-making test of neurocognitive functioning Three months after inclusion (T2)
Primary Health-related quality of life The Medical Outcome Study 36-item short form (SF-36), general health subscore (total range 0 - 100, where higher scores indicate better QoL) Three months after inclusion (T2)
Secondary Inflammation Plasma levels of C-reactive protein, high-sensitive assay (hsCRP). Higher levels indicate more inflammation Three months after inclusion (T2)
Secondary Working memory The Digit Span Test, total score, adopted from the Wechsler Adult Intelligence Scale (WAIS), 4th edition (WAIS-IV). Total range is from 0 - 30; higher scores indicate better working memory Three months after inclusion (T2)
Secondary Fatigue Chalder Fatigue Questionnaire (CFQ), total sum score (total range is from 0 - 33; higher scores indicate more fatigue) Three months after inclusion (T2)
Secondary Dyspnoea Medical Research Council dyspnoea scale. Total range is from 1 - 5, where higher scores indicate more dyspnoea Three months after inclusion (T2)
Secondary Global impression of change Patient Global Impression of Change (PGIC) inventory. Total range is from 1 - 7; higher scores imply that the health status is considered worsened Three months after inclusion (T2)
Secondary Cost-effectiveness Incremental cost-effectiveness ratio, using the 36-item short form (SF-36) general health subscore to determine quality-adjusted life years. Three months after inclusion (T2)
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