Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19 Illness (Long-COVID)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Massachusetts General Hospital
Updated on 6 August 2021

Summary

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.

Description

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.

Details
Condition Cognitive Symptoms, COVID19, Sequelae of; Infection, Sequelae of; Infection, Sequelae of; Infection
Treatment Niagen
Clinical Study IdentifierNCT04809974
SponsorMassachusetts General Hospital
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

History of SARS-CoV-2 PCR+ at least 2 months prior to study entry
SARS-CoV-2 negative (PCR) at study entry
Persistent cognitive difficulties (esp. "brain fog") that began around the time of the acute COVID-19
At least two neurological and/or physical symptoms that started at COVID-19 infection and are ongoing at study entry, including fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain
Willing and able to consent, complete all assessment and study procedures
Not pregnant or lactating

Exclusion Criteria

Any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc)
Clinically significant unstable medical condition that could affect safety or compliance with the study
Was intubated due to COVID-19
Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year
History of alcohol or other substance abuse or dependence within the past two years
Any significant systemic illness or medical condition that could affect safety or compliance with study
Current use of medications with psychoactive properties that may be deleteriously affecting cognition
Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide
Use of other investigational agents or interventions one month prior to entry and for the duration of the trial
If participating in the optional magnetic resonance imaging (MRI) sub-study: Any contraindication to undergo MRI
Pregnant women or women who are planning to become pregnant within 7 months from study entry
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