- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809974
Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19 Illness (Long-COVID)
Randomized, Placebo-controlled Parallel Group Clinical Trial of Nicotinamide Riboside to Evaluate NAD+ Levels in Individuals With Persistent Cognitive and Physical Symptoms After COVID-19 Illness ("Long-COVID")
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Isabel Abril, BA
- Phone Number: 617-726-9915
- Email: COVIDNiagenStudy@mgh.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02129
- Clinical Translational Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 with 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo: 40 participants will take placebo in the form of a capsule.
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The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
Other Names:
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Experimental: Niagen
Supplement: 60 participants will take Niagen 2000mg in the form of capsules daily.
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The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the effect of Niagen on cognitive functioning as measured by executive functioning and memory composite scores.
Time Frame: Baseline, 12 and 22 weeks
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The investigators will examine the effect of Niagen on cognitive functioning through neuropsychological test scores that form executive functioning and memory composite scores.
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Baseline, 12 and 22 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the effect of Niagen in depression symptoms
Time Frame: Baseline and every 5 weeks for 22 weeks
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Depression will be measured using the Beck Depression Inventory
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Baseline and every 5 weeks for 22 weeks
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Examine the effect of Niagen in anxiety symptoms
Time Frame: Baseline and every 5 weeks for 22 weeks
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Anxiety symptoms will be measured using the Beck Anxiety Inventory
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Baseline and every 5 weeks for 22 weeks
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Examine the effect of Niagen in COVID-related physical symptoms
Time Frame: Baseline and every 5 weeks for 22 weeks
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COVID-related symptoms will be measured using a COVID symptom checklist that assesses number and severity of symptoms.
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Baseline and every 5 weeks for 22 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edmarie Guzman-Velez, PhD, Massachusetts General Hospital and Harvard Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurologic Manifestations
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Neurobehavioral Manifestations
- Post-Acute COVID-19 Syndrome
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Niacinamide
Other Study ID Numbers
- 2021P000158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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