Mental Intervention and Nicotinamide Riboside Supplementation in Long Covid
NCT ID: NCT05703074
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
310 participants
INTERVENTIONAL
2023-01-30
2025-07-31
Brief Summary
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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 (trail making 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 inflammation and 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 treatment periods 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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MBRT and NR
Psychological therapy and dietary supplement
Nicotinamide Riboside (NR)
4 capsules (a total of 1000 mg) 2 times daily for 84 days
Mind-body reprocessing therapy (MBRT)
4-6 face-to-face meetings over 3-4 weeks, unlimited access to designated online resources.
MBRT and placebo
Psychological therapy and placebo dietary supplement
Mind-body reprocessing therapy (MBRT)
4-6 face-to-face meetings over 3-4 weeks, unlimited access to designated online resources.
Placebo
4 capsules (empty) 2 times daily for 84 days.
Care as usual and NR
No psychological therapy (information only) and dietary supplement
Nicotinamide Riboside (NR)
4 capsules (a total of 1000 mg) 2 times daily for 84 days
Care as usual
A brief self-help leaflet on long COVID is distributed, otherwise care as usual by the general practitioner
Care as usual and placebo
No psychological therapy (information only) and placebo dietary supplement
Care as usual
A brief self-help leaflet on long COVID is distributed, otherwise care as usual by the general practitioner
Placebo
4 capsules (empty) 2 times daily for 84 days.
Interventions
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Nicotinamide Riboside (NR)
4 capsules (a total of 1000 mg) 2 times daily for 84 days
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
Placebo
4 capsules (empty) 2 times daily for 84 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* Sustained organ damage (lung, heart, brain) following acute, serious Covid-19
* Pregnancy.
* Bedridden
* Insufficient command of Norwegian
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Akershus
OTHER
Responsible Party
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Vegard Wyller
Professor
Principal Investigators
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Torbjørn Omland, PhD
Role: STUDY_CHAIR
Akershus University Hospital/University of Oslo
Locations
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Akershus University Hospital
Lørenskog, , Norway
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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983971636
Identifier Type: -
Identifier Source: org_study_id
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