Niagen for Post-COVID Syndrome

Overseen By Isabel Abril, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must not be taking: Psychoactive medications

Disqualifiers: CNS disease, Unstable psychiatric, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 22 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests Niagen, a Vitamin B3 supplement, on people with long-term COVID-19 symptoms. It aims to see if the supplement can improve thinking skills, mood, and physical health by boosting cell energy and brain function.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications with psychoactive properties that might negatively affect your thinking. Also, you cannot use other investigational agents or interventions for one month before joining the trial and during the trial.

How is the drug Niagen unique for treating post-COVID syndrome?

Niagen is unique because it is a form of nicotinamide riboside, a vitamin B3 derivative, which may help improve cellular energy production and repair, potentially addressing fatigue and other symptoms of post-COVID syndrome. Unlike other treatments, it focuses on enhancing cellular health rather than targeting specific symptoms or using immune-based therapies. ^{1 2 3 4 5}

Research Team

Edmarie Guzman-Velez, PhD

Principal Investigator

Massachusetts General Hospital and Harvard Medical School

Eligibility Criteria

This trial is for individuals who have had COVID-19 and are experiencing ongoing neurological or physical symptoms like fatigue, headaches, or 'brain fog' at least two months after infection. Participants must not be pregnant, lactating, or have a history of hypersensitivity to nicotinamide riboside. They should not be using psychoactive medications that affect cognition and must not have any major psychiatric illness within the last year.

Inclusion Criteria

You have at least two ongoing symptoms like fatigue, weakness, headache, loss of smell, numbness, shortness of breath, loss of appetite, palpitations, hair loss, muscle or chest pain that started with COVID-19 infection.

You have tested negative for the SARS-CoV-2 virus before joining the study.

Willing and able to consent, complete all assessment and study procedures

Exclusion Criteria

You are allergic to nicotinamide riboside or nicotinamide mononucleotide.

You are currently taking medications that may harm your ability to think clearly.

Pregnant women or women who are planning to become pregnant within 7 months from study entry

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niagen or placebo daily, with assessments every 5 weeks

22 weeks

Baseline and every 5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Niagen

Trial Overview The study tests Niagen, a dietary supplement, to see if it helps people with Long-COVID recover from persistent cognitive and physical symptoms. Sixty percent of participants will receive Niagen while forty percent will get a placebo (PBO). The effects will be measured through various assessments including cognitive tests and biomarkers.

Participant Groups

Group I: Niagen Experimental Treatment 1 Intervention

Supplement: 60 participants will take Niagen 2000mg in the form of capsules daily.

Group II: Placebo Placebo Group 1 Intervention

Placebo: 40 participants will take placebo in the form of a capsule.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Pharmacological trials evaluating treatment options for neuropsychiatric symptoms in post-COVID. A narrative review]. [2023]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Asthenic post-COVID syndrome]. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Adipose-derived, autologous mesenchymal stem cell therapy for patients with post-COVID-19 syndrome: an intermediate-size expanded access program. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of retinal and choroidal parameters as neurodegeneration biomarkers in patients with post-covid-19 syndrome. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic plasma exchange for persistent encephalopathy associated with Covid-19. [2021]