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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |