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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Niagen, a dietary supplement, can aid recovery from lingering COVID-19 symptoms. Many individuals, often called "long-haulers," experience ongoing issues like brain fog, fatigue, or loss of smell months after their initial COVID infection. Participants will take either Niagen or a placebo to determine if it improves these symptoms. Those who had COVID at least two months ago and continue to experience symptoms such as brain fog or fatigue might be suitable for this trial. As a Phase 4 trial, Niagen is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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.

What is the safety track record for Niagen?

Research has shown that Niagen, a type of vitamin B3, is generally safe for people. Studies have found it to be well-tolerated, with few reports of side effects. In one study, taking a Niagen supplement helped COVID-19 patients recover faster without causing significant problems. Another study suggested that Niagen might aid those experiencing fatigue after COVID-19, again showing no major safety issues.

Since this trial is in a later stage, Niagen has already undergone extensive safety testing. As a dietary supplement, any side effects are likely to be mild. Overall, current evidence suggests that Niagen is a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for post-COVID syndrome that often focus on managing symptoms with medications like pain relievers or steroids, Niagen offers a unique approach by potentially addressing the root of cellular energy production. Niagen is a form of nicotinamide riboside, a form of vitamin B3, which is thought to boost levels of NAD+ in the body, a crucial molecule for energy metabolism and cellular repair. Researchers are excited about Niagen because it might enhance the body’s natural ability to recover by improving cellular health, offering a promising new avenue for addressing the lingering effects of post-COVID syndrome.

What evidence suggests that Niagen might be an effective treatment for Post-COVID Syndrome?

Research has shown that Niagen, a dietary supplement, might help people with Long-COVID. Some studies suggest that Niagen could improve the quality of life for those experiencing symptoms months after a COVID-19 infection. In this trial, participants will receive either Niagen or a placebo. Niagen increases levels of NAD+ in the body, which is important for cell energy and repair. Evidence indicates that treatments involving NAD+ may help reduce tiredness in some patients. Although more research is needed, these early findings offer promise for those dealing with lingering COVID-19 symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Edmarie Guzman-Velez, PhD

Principal Investigator

Massachusetts General Hospital and Harvard Medical School

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04809974

Clinical Trial of Niagen to Examine Recovery in People ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05703074

Study Details | NCT05703074 | Mental Intervention and ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9659683/

Treatment of Long COVID or Post COVID syndrome Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19 Illness (Long-COVID). [online 2021] ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862402/

Low-dose naltrexone and NAD+ for the treatment of ... Our data suggest treatment with LDN and NAD+ is safe and may be beneficial in a subset of patients with persistent fatigue after COVID-19.

5. discover.nutrition.org discover.nutrition.org/content/sponsored-webinar-crossroads-nad-and-long-covid-emerging-data-nutrition-interventions

At the Crossroads of NAD+ and Long COVID About 15% still experience symptoms a year later, driving urgent demand for effective treatments. Niagen Bioscience co-funded a randomized, double-blind, ...

6. massgeneral.org massgeneral.org/neurology/mccance-center/2022-7-long-covid-clinical-trial

2022-7-long-covid-clinical-trial Steven Arnold and her collaborators have been studying the effects of a vitamin B3 complex called Nicotinamide riboside or Niagen on the NAD+ ...

7. fda.gov fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chromadex-607692-11172020

ChromaDex MARCS-CMS 607692 — November 17, 2020 ChromaDex announces study results showing nutritional protocol including nicotinamide riboside plus standard of care reduces recovery time in COVID-19 patients ...