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

Covid19 Clinical Trial

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809974
• Other study ID #: 2021P000158
• Status: Completed
• Phase: Phase 4
• Start date: July 22, 2021
• Est. completion date: February 23, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 23, 2024
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Symptom
• COVID-19
• Covid19
• Neurobehavioral Manifestations
• Sequelae of; Infection

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Translational Research Unit	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 and 22 weeks
Secondary	Examine the effect of Niagen in depression symptoms	Depression will be measured using the Beck Depression Inventory	Baseline and every 5 weeks for 22 weeks
Secondary	Examine the effect of Niagen in anxiety symptoms	Anxiety symptoms will be measured using the Beck Anxiety Inventory	Baseline and every 5 weeks for 22 weeks
Secondary	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.	Baseline and every 5 weeks for 22 weeks