Long COVIDPhase 2MINIRICONCT05703074
Mental Intervention and Nicotinamide Riboside Supplementation in Long Covid
A Phase 2 study testing Nicotinamide Riboside (NR), Mind-body reprocessing therapy (MBRT) and Care as usual in people with Long COVID, run by University Hospital, Akershus at 1 site in Norway.
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 functional brain alterations associated with psychosocial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Nicotinamide Riboside (NR), Mind-body reprocessing therapy (MBRT) and Care as usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteNorway
- Study dates
- 30 Jan 2023to 23 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of a Mental Intervention Program vs. Usual Care and Nicotinamide Riboside (NR) vs. Placebo for Improving Health-related Quality of Life in Long Covid: A 2 x 2 Factorial Randomized Controlled Trial
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 functional brain alterations associated with 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 functional brain alterations, 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 (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).
- Conditions
- Long COVID
- Being tested
- Nicotinamide Riboside (NR), Mind-body reprocessing therapy (MBRT), Care as usual, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
4 capsules (a total of 1000 mg) 2 times daily for 84 days
Mind-body reprocessing therapy (MBRT)Behavioural
4-6 face-to-face meetings over 3-4 weeks, unlimited access to designated online resources.
Care as usualBehavioural
A brief self-help leaflet on long COVID is distributed, otherwise care as usual by the general practitioner
PlaceboDietary supplement
4 capsules (empty) 2 times daily for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| MBRT and NR | Other | Psychological therapy and dietary supplement Receives: Dietary Supplement: Nicotinamide Riboside (NR); Behavioral: Mind-body reprocessing therapy (MBRT) |
| MBRT and placebo | Other | Psychological therapy and placebo dietary supplement Receives: Behavioral: Mind-body reprocessing therapy (MBRT); Dietary Supplement: Placebo |
| Care as usual and NR | Other | No psychological therapy (information only) and dietary supplement Receives: Dietary Supplement: Nicotinamide Riboside (NR); Behavioral: Care as usual |
| Care as usual and placebo | Other | No psychological therapy (information only) and placebo dietary supplement Receives: Behavioral: Care as usual; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three months after inclusion (T2)
Secondary outcomes (6)
Inflammation
Plasma levels of C-reactive protein, high-sensitive assay (hsCRP). Higher levels indicate more inflammation
Measured: Three months after inclusion (T2)
Executive functioning
The Trail Making test, part B, seconds. Longer time indicates poorer executive functioning
Measured: Three months after inclusion (T2)
Fatigue
Chalder Fatigue Questionnaire (CFQ), total sum score (total range is from 0 - 33; higher scores indicate more fatigue)
Measured: Three months after inclusion (T2)
Dyspnoea
Medical Research Council dyspnoea scale. Total range is from 0 - 4, where higher scores indicate more dyspnoea
Measured: Three months after inclusion (T2)
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
Measured: Three months after inclusion (T2)
Cost-effectiveness
Incremental cost-effectiveness ratio, using the 36-item short form (SF-36) general health subscore to determine quality-adjusted life years.
Measured: Three months after inclusion (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start30 Jan 2023
- Primary completion23 Sep 2024
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2 x 2 factorial randomized controlled trial, where Mind-Body Reprocessing Therapy (MBRT) is compared with care as usual and Nicotinamide Riboside (NR) is compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Wyller, University Hospital, Akershus
- Investigators
- Torbjørn Omland, PhD, Study chair, Akershus University Hospital/University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703074
- Sponsor's protocol ID
- 983971636
- Acronym
- MINIRICO
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Mental Intervention Program vs. Usual Care and Nicotinamide Riboside (NR) vs. Placebo for Improving Health-related Quality of Life in Long Covid: A 2 x 2 Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05703074
- Acronym / sponsor ID
- MINIRICO / 983971636
- Conditions
- Long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 functional brain alterations associated with 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 functional brain alterations, 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 (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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A 2 x 2 factorial randomized controlled trial, where Mind-Body Reprocessing Therapy (MBRT) is compared with care as usual and Nicotinamide Riboside (NR) is compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| MBRT and NR | Other | Dietary Supplement: Nicotinamide Riboside (NR), Behavioral: Mind-body reprocessing therapy (MBRT)Psychological therapy and dietary supplement |
| MBRT and placebo | Other | Behavioral: Mind-body reprocessing therapy (MBRT), Dietary Supplement: PlaceboPsychological therapy and placebo dietary supplement |
| Care as usual and NR | Other | Dietary Supplement: Nicotinamide Riboside (NR), Behavioral: Care as usualNo psychological therapy (information only) and dietary supplement |
| Care as usual and placebo | Other | Behavioral: Care as usual, Dietary Supplement: PlaceboNo psychological therapy (information only) and placebo dietary supplement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide Riboside (NR)4 capsules (a total of 1000 mg) 2 times daily for 84 days | Dietary supplement | Care as usual and NR, MBRT and NR |
| Mind-body reprocessing therapy (MBRT)4-6 face-to-face meetings over 3-4 weeks, unlimited access to designated online resources. | Behavioural | MBRT and NR, MBRT and placebo |
| Care as usualA brief self-help leaflet on long COVID is distributed, otherwise care as usual by the general practitioner | Behavioural | Care as usual and NR, Care as usual and placebo |
| Placebo4 capsules (empty) 2 times daily for 84 days. | Dietary supplement | Care as usual and placebo, MBRT and placebo |
Primary outcome
Health-related quality of life
Time frame: Three months after inclusion (T2)
The Medical Outcome Study 36-item short form (SF-36), general health subscore (total range 0 - 100, where higher scores indicate better QoL)
6 secondary outcomes
Inflammation
Time frame: Three months after inclusion (T2)
Executive functioning
Time frame: Three months after inclusion (T2)
Fatigue
Time frame: Three months after inclusion (T2)
Dyspnoea
Time frame: Three months after inclusion (T2)
Global impression of change
Time frame: Three months after inclusion (T2)
Cost-effectiveness
Time frame: Three months after inclusion (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torbjørn Omland, PhD study chair
Akershus University Hospital/University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside (NR), Mind-body reprocessing therapy (MBRT) and Care as usual in people with Long COVID, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: Three months after inclusion (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.