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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)

Primary Purpose

Covid19, Sequelae of; Infection, Cognitive Symptom

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Niagen

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Niagen, vitamin B3, Long-COVID, Long-haulers, Dietary supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Translational Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Niagen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Examine the effect of Niagen on cognitive functioning as measured by executive functioning and memory composite scores.

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

Examine the effect of Niagen in depression symptoms

Depression will be measured using the Beck Depression Inventory

Examine the effect of Niagen in anxiety symptoms

Anxiety symptoms will be measured using the Beck Anxiety Inventory

Examine the effect of Niagen in COVID-related physical symptoms

COVID-related symptoms will be measured using a COVID symptom checklist that assesses number and severity of symptoms.

Full Information

NCT ID

NCT04809974

First Posted

March 19, 2021

Last Updated

August 23, 2022

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04809974

Brief Title

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

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")

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Sequelae of; Infection, Cognitive Symptom

Keywords

Niagen, vitamin B3, Long-COVID, Long-haulers, Dietary supplement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded, randomized, parallel group, placebo-controlled design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Niagen

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Niagen

Other Intervention Name(s)

Nicotinamide Riboside, TruNiagen, Vitamin B3

Intervention Description

The intervention consists of taking Niagen and completing all tasks divided into 6 visits.

Primary Outcome Measure Information:

Title

Examine the effect of Niagen on cognitive functioning as measured by executive functioning and memory composite scores.

Description

The investigators will examine the effect of Niagen on cognitive functioning through neuropsychological test scores that form executive functioning and memory composite scores.

Time Frame

Baseline, 12 and 22 weeks

Secondary Outcome Measure Information:

Title

Examine the effect of Niagen in depression symptoms

Description

Depression will be measured using the Beck Depression Inventory

Time Frame

Baseline and every 5 weeks for 22 weeks

Title

Examine the effect of Niagen in anxiety symptoms

Description

Anxiety symptoms will be measured using the Beck Anxiety Inventory

Time Frame

Baseline and every 5 weeks for 22 weeks

Title

Examine the effect of Niagen in COVID-related physical symptoms

Description

COVID-related symptoms will be measured using a COVID symptom checklist that assesses number and severity of symptoms.

Time Frame

Baseline and every 5 weeks for 22 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Isabel Abril, BA

Phone

617-726-9915

COVIDNiagenStudy@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edmarie Guzman-Velez, PhD

Organizational Affiliation

Massachusetts General Hospital and Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Translational Research Unit

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica A Gerber

Phone

617-724-1992

jgerber2@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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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