Status:
COMPLETED
Clinical Trial of Niagen to Examine Recovery in People With Persistent Cognitive and Physical Symptoms After COVID-19
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Covid19
Sequelae of; Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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" "L...
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, re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04809974
Start Date
August 28 2021
End Date
February 23 2024
Last Update
August 5 2025
Active Locations (1)
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1
Clinical Translational Research Unit
Boston, Massachusetts, United States, 02129