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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Niacinamide

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.