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The study will assess whether Niagen, a safe dietary supplement, improves recovery of COVID-19 related symptoms in individuals who were infected at least 2 months prior to study entry ("Long-COVID" "Long-haulers"). 60% of participants will receive Niagen and 40% will receive PBO. Outcomes will consist of standardized cognitive, neuropsychiatric, physical, functional and biomarker assessments.
This study will recruit people who were infected with COVID-19 at least 2 months ago and continue to experience symptoms related to infection. Initially thought to be an acute illness like the flu, resulting in death for some or full recovery in most, scientists and clinicians are now appreciating that substantial numbers of COVID-19 illness survivors experience persistent, significant and sometimes disabling symptoms. Variously called "Long-COVID," "COVID long-haulers," or "chronic COVID syndrome", some of the most prominent symptoms are neurologic and neuropsychiatric, including cognitive impairment ('brain fog'), headache, fatigue, muscle aches and weakness, shortness of breath, hair loss and pain, among others. In this research study the investigators want to learn about whether taking Niagen (also known as Nicotinamide riboside, or NR), a daily supplement containing a form of Vitamin B3, can improve recovery of cognitive function, mood, and physical health in individuals who were infected with COVID-19 and continue to experience "brain fog" and other neurological and physical symptoms. The investigators think that this supplement may help improve thinking skills and other symptoms, and improve quality of life, in individuals who had COVID-19.
Participants will complete the following at baseline and every 5 weeks: 1) a standard cognitive battery and subjective cognitive complaints scales; 2) mood measures; 3) assessments of physical functioning, as well as of other common COVID-19-related symptoms; 4) blood draw; and 5) 2 optional MRIs. Participants will also wear a Fitbit and complete questionnaires to assess sleep and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo: 40 participants will take placebo in the form of a capsule. |
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| Niagen | Experimental | Supplement: 60 participants will take Niagen 2000mg in the form of capsules daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niagen | Drug | The intervention consists of taking Niagen and completing all tasks divided into 6 visits. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of Niagen on NAD+ and Cognitive Functioning | Cognitive outcomes were assessed using the Everyday Cognition (ECog) scale, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Trail Making Test B (TMT-B). The ECog total score ranges from 39 to 156, and individual domain scores range from 1 to 4. Higher scores indicate greater subjective cognitive decline since COVID-19 infection. Individual RBANS index scores range from 40 to 160, and the Sum of Index Scores (sum of five index scores) ranges from 200 to 800. Higher index scores reflect better cognitive performance. The TMT-B score is the completion time in seconds, with a maximum time of 5 minutes. A lower time is indicative of a better performance. Change scores reflect the difference from Baseline to Week 10, and from Week 10 to Week 20. Positive change scores on the ECog indicate worsening subjective cognitive decline. Positive change scores on the RBANS indicate improvement. Positive change scores in the TMT-B represent worsening performance. | Baseline, Week 10 and Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Niagen on NAD+ and Depression Symptoms | Depression symptoms were assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire measuring severity of depression symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Baseline, Week 10 and Week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmarie Guzman-Velez, PhD | Massachusetts General Hospital and Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Translational Research Unit | Boston | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41357333 | Derived | Wu CY, Reynolds WC, Abril I, McManus AJ, Brenner C, Gonzalez-Irizarry G, Gutierrez-Martinez L, Sun O, Rosand J, Tanzi RE, Arnold SE, Guzman-Velez E. Effects of nicotinamide riboside on NAD+ levels, cognition, and symptom recovery in long-COVID: a randomized controlled trial. EClinicalMedicine. 2025 Nov 12;89:103633. doi: 10.1016/j.eclinm.2025.103633. eCollection 2025 Nov. |
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72 participants provided informed consent and completed an in-person screening visit. Eleven participants were deemed ineligible based on screening assessments and did not proceed. The remaining 61 participants entered a two-week placebo lead-in phase, during which 3 participants withdrew from the study. A total of 58 participants completed the lead-in phase, attended the baseline visit, and were randomized to study intervention.
Participants were enrolled between August 2021 and September 2023. They were recruited using flyers posted at Massachusetts General Hospital (main and Charlestown campuses), Partners Rally for Research, community events, physician referrals, and outreach to local institutions. Eligibility was assessed via telephone interview and an in-person screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lead-in Phase | Participants assigned to the Lead-in Phase received placebo capsules at the screening visit and were instructed to take four capsules in the morning and four capsules in the evening (8 capsules daily) for two weeks. All capsules were visually identical to the active study drug and administered using the same dosing instructions as the randomized phase. |
| FG001 | Placebo | Participants randomized to the placebo group received placebo capsules twice daily for 10 weeks following a two-week placebo lead-in period. After the initial 10 weeks, participants crossed over to receive NR (TruNiagen, Chromadex) 1000 mg twice daily for an additional 10 weeks. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. |
| FG002 | Niagen | Participants randomized to the Niagen group received NR (TruNiagen, Chromadex) 1000 mg twice daily for 20 weeks following a two-week placebo lead-in period. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-in Phase |
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| Randomized Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to the placebo group received placebo capsules twice daily for 10 weeks following a two-week placebo lead-in period. After the initial 10 weeks, participants crossed over to receive NR (TruNiagen, Chromadex) 1000 mg twice daily for an additional 10 weeks. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Niagen on NAD+ and Cognitive Functioning | Cognitive outcomes were assessed using the Everyday Cognition (ECog) scale, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Trail Making Test B (TMT-B). The ECog total score ranges from 39 to 156, and individual domain scores range from 1 to 4. Higher scores indicate greater subjective cognitive decline since COVID-19 infection. Individual RBANS index scores range from 40 to 160, and the Sum of Index Scores (sum of five index scores) ranges from 200 to 800. Higher index scores reflect better cognitive performance. The TMT-B score is the completion time in seconds, with a maximum time of 5 minutes. A lower time is indicative of a better performance. Change scores reflect the difference from Baseline to Week 10, and from Week 10 to Week 20. Positive change scores on the ECog indicate worsening subjective cognitive decline. Positive change scores on the RBANS indicate improvement. Positive change scores in the TMT-B represent worsening performance. | Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 10 and Week 20 |
Adverse events were systematically collected at every visit, for a total of 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lead in | Participants assigned to the Lead-in Phase received placebo capsules at the screening visit and were instructed to take four capsules in the morning and four capsules in the evening (8 capsules daily) for two weeks. All capsules were visually identical to the active study drug and were administered using the same dosing instructions as those in the randomized phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment | Unrelated to Niagen: One serious adverse event (suicidal ideation) occurred in the Niagen group. This event was deemed unrelated to the study drug or procedures by the participant and several licensed clinicians. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 possibly related in placebo group; 1 not related in Niagen group. |
The sample size of individuals who completed the clinical trial was relatively small, and COVID-19 infection status was based on self-report. Moreover, we exclusively included individuals experiencing brain fog, preventing us from assessing whether NR could be beneficial for those with different long-COVID symptom profiles.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edmarie Guzmán-Vélez | Massachusetts General Hospital | 6176436107 | eguzman-velez@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2024 | Apr 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2024 | Apr 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007239 | Infections |
| D019954 | Neurobehavioral Manifestations |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Double-blinded, randomized, parallel group, placebo-controlled design
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| Effect of Niagen on NAD+ and Anxiety Symptoms | Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire measuring severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Baseline, Week 10 and Week 20 |
| Effect of Niagen on NAD+ and Other COVID-related Symptoms | Fatigue was assessed using the Fatigue Severity Scale (FSS), a 9-item self-report measure with scores ranging from 1 to 7; higher scores indicate greater fatigue severity. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure with scores ranging from 0 to 21; higher scores indicate poorer sleep quality. All values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Baseline, Week 10 and Week 20 |
| Visit 1 |
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| Visit 2 |
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| Visit 3 |
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| Visit 4 |
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| Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Niagen | Participants randomized to the Niagen group received NR (TruNiagen, Chromadex) 1000 mg twice daily for 20 weeks following a two-week placebo lead-in period. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Education | Number | Participants |
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| Secondary | Effect of Niagen on NAD+ and Depression Symptoms | Depression symptoms were assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire measuring severity of depression symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 10 and Week 20 |
|
|
|
| Secondary | Effect of Niagen on NAD+ and Anxiety Symptoms | Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire measuring severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 10 and Week 20 |
|
|
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| Secondary | Effect of Niagen on NAD+ and Other COVID-related Symptoms | Fatigue was assessed using the Fatigue Severity Scale (FSS), a 9-item self-report measure with scores ranging from 1 to 7; higher scores indicate greater fatigue severity. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure with scores ranging from 0 to 21; higher scores indicate poorer sleep quality. All values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. | Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 10 and Week 20 |
|
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|
| 0 |
| 72 |
| 0 |
| 72 |
| 1 |
| 72 |
| EG001 | Placebo | Participants randomized to the Placebo group took four capsules in the morning and four capsules in the evening (8 capsules daily) for 10 weeks following a two-week placebo lead-in period. After the initial 10 weeks, participants crossed over to receive 1000 mg of NR (Niagen) twice daily for an additional 10 weeks. Dosing was double-blinded. Participants completed clinical assessments and cognitive testing at baseline, Visit 2, and Visit 4, and provided blood at every visit since baseline. | 0 | 21 | 0 | 21 | 19 | 21 |
| EG002 | Niagen | Participants randomized to the NR group received 1000 mg of NR (Niagen) twice daily for 20 weeks following a two-week placebo lead-in period. Dosing was double-blinded. Participants completed clinical assessments and cognitive testing at baseline, Visit 2, and Visit 4, and provided blood at every visit since baseline. | 0 | 37 | 1 | 37 | 25 | 37 |
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| Allergic reaction | Immune system disorders | Systematic Assessment | 2 not related in Niagen group. |
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| Arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Back spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Bronchitis | Infections and infestations | Systematic Assessment | 1 not related in placebo group. |
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| Brusing | Injury, poisoning and procedural complications | Systematic Assessment | 1 probably related in placebo group. |
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| Burn | Injury, poisoning and procedural complications | Systematic Assessment | 1 not related in Niagen group. |
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| Chest pain | Cardiac disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Cold hands | Vascular disorders | Systematic Assessment | 1 not related in placebo group. |
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| Cold Sweats | General disorders | Systematic Assessment | 1 possibly related in placebo group. |
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| Conjunctivitis | Eye disorders | Systematic Assessment | 1 not related in placebo group. |
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| Constipation | Gastrointestinal disorders | Systematic Assessment | 1 not related in Niagen group; 1 possibly related in placebo group. |
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| COVID-19 infection | Infections and infestations | Systematic Assessment | 4 not related in Niagen group; 1 not related in placebo group. |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | 1 not related in Niagen group; 1 not related in placebo group |
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| Dizziness | Nervous system disorders | Systematic Assessment | 1 possibly related in placebo group; 1 possibly related in Niagen group. |
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| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 possibly related in Niagen group. |
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| Edema of hand | Vascular disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Edema of leg | Vascular disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Facial flushing | Vascular disorders | Systematic Assessment | 1 possibly related and 1 probably related in Niagen group. |
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| Facial pain | Nervous system disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment | 1 possibly related in placebo group and 1 not related in Niagen group. |
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| Falx cerebri calcification | Investigations | Systematic Assessment | 1 not related in placebo group. |
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| GI discomfort | Gastrointestinal disorders | Systematic Assessment | 1 possibly related in placebo group; 1 possibly related and 3 not related in Niagen group. |
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| Hand trembling | Nervous system disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Headache | Nervous system disorders | Systematic Assessment | 1 probably related in Niagen group; 2 possibly related in placebo group |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment | 2 possibly related in placebo group. |
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| Worsening IBS | Gastrointestinal disorders | Systematic Assessment | 1 possibly related in Niagen group. |
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| Increased eructation | Gastrointestinal disorders | Systematic Assessment | 1 possibly related in placebo group. |
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| Infection | Infections and infestations | Systematic Assessment | 1 not related in placebo group. |
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| Injury | Injury, poisoning and procedural complications | Systematic Assessment | 3 not related in placebo group. |
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| Joint ache | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 possibly related in placebo group. |
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| Kidney stone | Renal and urinary disorders | Systematic Assessment | 1 not related in placebo group. |
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| Leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 probably related and 1 not related in Niagen group. |
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| Lightheadedness | Nervous system disorders | Systematic Assessment | 1 definitely related in Niagen group. |
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| Low vitamin B12 | Metabolism and nutrition disorders | Systematic Assessment | 1 possibly related in placebo group. |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 probably related in placebo group. |
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| Muscle strain | Musculoskeletal and connective tissue disorders | Systematic Assessment | 2 not related in placebo group. |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | 1 definitely, 1 probably, and 1 possibly related in Niagen group; 1 probably and 1 possibly related in placebo group. |
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| Night sweats | General disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Nocturia | Renal and urinary disorders | Systematic Assessment | 1 not related in placebo group. |
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| Otitis media | Ear and labyrinth disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Paresthesia in extremities | Nervous system disorders | Systematic Assessment | 1 possibly related in Niagen group. |
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| Paroxysmal blood pressure | Vascular disorders | Systematic Assessment | 1 not related in lead in group. |
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| Pineal cyst | Investigations | Systematic Assessment | 1 not related in Niagen group. |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | 2 not related in Niagen group. |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 definitely, 2 possibly, and 1 not related in Niagen group. |
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| Sinus infection | Infections and infestations | Systematic Assessment | 1 not related in Niagen group; 1 not related in placebo group. |
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| Restless leg | Nervous system disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Stiffness in finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 possibly related in Niagen group. |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment | 7 not related in Niagen group; 4 not related in placebo group. |
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| Urine odor | Renal and urinary disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment | 1 not related in Niagen group. |
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| Vertigo | Nervous system disorders | Systematic Assessment | 1 definitely and 1 not related in Niagen group; 1 not related in placebo group. |
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| Viral syndrome | Infections and infestations | Systematic Assessment | 1 not related in Niagen group. |
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| Worsening bile reflux | Gastrointestinal disorders | Systematic Assessment | 1 possibly related in placebo group. |
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| Worsening cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 1 not related in placebo group. |
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| Worsening insomina | Psychiatric disorders | Systematic Assessment | 2 not related in Niagen group. |
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| Worsening sleep | Psychiatric disorders | Systematic Assessment | 1 possibly related and 1 not related in Niagen group; 1 not related in placebo group. |
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| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| BDI (Week 10 to Week 20) |
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| BAI (Week 10 to Week 20) |
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| FSS Total Fatigue (Week 10 to Week 20) |
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