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

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ClinicalTrials.gov Identifier: NCT04809974
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Edmarie Guzman-Velez, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Sequelae of; Infection Cognitive Symptom Drug: Niagen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, randomized, parallel group, placebo-controlled design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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")
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo: 40 participants will take placebo in the form of a capsule.
Drug: Niagen
The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
Other Names:
  • Nicotinamide Riboside
  • TruNiagen
  • Vitamin B3

Experimental: Niagen
Supplement: 60 participants will take Niagen 2000mg in the form of capsules daily.
Drug: Niagen
The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
Other Names:
  • Nicotinamide Riboside
  • TruNiagen
  • Vitamin B3




Primary Outcome Measures :
  1. Examine the effect of Niagen on cognitive functioning as measured by executive functioning and memory composite scores. [ Time Frame: Baseline, 12 and 22 weeks ]
    The investigators will examine the effect of Niagen on cognitive functioning through neuropsychological test scores that form executive functioning and memory composite scores.


Secondary Outcome Measures :
  1. Examine the effect of Niagen in depression symptoms [ Time Frame: Baseline and every 5 weeks for 22 weeks ]
    Depression will be measured using the Beck Depression Inventory

  2. Examine the effect of Niagen in anxiety symptoms [ Time Frame: Baseline and every 5 weeks for 22 weeks ]
    Anxiety symptoms will be measured using the Beck Anxiety Inventory

  3. Examine the effect of Niagen in COVID-related physical symptoms [ Time Frame: Baseline and every 5 weeks for 22 weeks ]
    COVID-related symptoms will be measured using a COVID symptom checklist that assesses number and severity of symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809974


Contacts
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Contact: Leidys Gutiérrez-Martínez, MD 617-643-5147 COVIDNiagenStudy@mgh.harvard.edu
Contact: Gabriel J González-Irizarry, BS 617-726-2671 ggonzalezirizarry@mgh.harvard.edu

Locations
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United States, Massachusetts
Clinical Translational Research Unit Recruiting
Boston, Massachusetts, United States, 02129
Contact: Jessica A Gerber    617-724-1992    jgerber2@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Edmarie Guzman-Velez, PhD Massachusetts General Hospital and Harvard Medical School
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Responsible Party: Edmarie Guzman-Velez, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04809974    
Other Study ID Numbers: 2021P000158
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edmarie Guzman-Velez, Massachusetts General Hospital:
Niagen
vitamin B3
Long-COVID
Long-haulers
Dietary supplement
Additional relevant MeSH terms:
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COVID-19
Neurobehavioral Manifestations
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Niacinamide
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex