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")
Verified date | March 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Translational Research Unit | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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 |
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