Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Nicotinamide Riboside on the Clinical Outcome of Covid-19 in the Elderly (NR-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407390
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
Bispebjerg Hospital
Elysium Health
Information provided by (Responsible Party):
Morten Scheibye-Knudsen, University of Copenhagen

Brief Summary:

The purpose of this study is to investigate whether nicotinamide riboside supplementation can attenuate the severity of SARS-CoV-2 infections in elderly patients.

A major event in aging is the loss of the central metabolite nicotinamide adenine dinucleotide (NAD+) that appear to be important in the proinflammatory environment that occur during aging. Notably, recent work from our and other groups suggest that aging can be ameliorated by even a short-term treatment of the NAD+ precursor nicotinamide riboside. Nicotinamide riboside has recently been shown to be able to return aging tissues to a younger state even after short term treatment. This vitamin B3- analog is naturally occurring, is readily taken up through oral administration and has been tested in human trials with few side effects. In this randomized double blinded case-control trial, the investigators will treat elderly (>70 year old) COVID19 patients with 1 g of nicotinamide riboside (NR-E) or placebo for 2 weeks and investigate if this affects the clinical course of the disease.


Condition or disease Intervention/treatment Phase
COVID Dietary Supplement: Nicotinamide riboside Dietary Supplement: Placebo Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blind case-control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Nicotinamide Riboside on the Clinical Outcome of Covid-19 in the Elderly. A Randomized Double-blind, Placebo-controlled Trial of Nicotinamide Riboside NR-COVID19
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Patients receiving placebo.
Dietary Supplement: Placebo
Placebo

Experimental: NR
Patients receiving nicotinamide riboside (NR-E)
Dietary Supplement: Nicotinamide riboside
The patients will receive 1 g of nicotinamide riboside or placebo orally every morning for 14 days.




Primary Outcome Measures :
  1. Hypoxic respiratory failure [ Time Frame: Day 1 ]
    Hypoxic respiratory failure as defined by need for oxygen therapy

  2. Hypoxic respiratory failure [ Time Frame: Day 7 ]
    Hypoxic respiratory failure as defined by need for oxygen therapy

  3. Hypoxic respiratory failure [ Time Frame: Day 14 ]
    Hypoxic respiratory failure as defined by need for oxygen therapy

  4. Hypoxic respiratory failure [ Time Frame: Day 90 ]
    Hypoxic respiratory failure as defined by need for oxygen therapy


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Day 1 ]
    Overall mortality

  2. Mortality [ Time Frame: Day 7 ]
    Overall mortality

  3. Mortality [ Time Frame: Day 14 ]
    Overall mortality

  4. Mortality [ Time Frame: Day 90 ]
    Overall mortality

  5. Sepsis [ Time Frame: Day 1 ]
    Sepsis

  6. Sepsis [ Time Frame: Day 7 ]
    Sepsis

  7. Sepsis [ Time Frame: Day 14 ]
    Sepsis

  8. Sepsis [ Time Frame: Day 90 ]
    Sepsis

  9. Circulatory failure [ Time Frame: Day 1 ]
    Circulatory failure as defined by a need for interventions to support the circulatory system.

  10. Circulatory failure [ Time Frame: Day 7 ]
    Circulatory failure as defined by a need for interventions to support the circulatory system.

  11. Circulatory failure [ Time Frame: Day 14 ]
    Circulatory failure as defined by a need for interventions to support the circulatory system.

  12. Circulatory failure [ Time Frame: Day 90 ]
    Circulatory failure as defined by a need for interventions to support the circulatory system.

  13. Days in hospital [ Time Frame: Day 1 ]
    Days in hospital

  14. Days in hospital [ Time Frame: Day 7 ]
    Days in hospital

  15. Days in hospital [ Time Frame: Day 14 ]
    Days in hospital

  16. Days in hospital [ Time Frame: Day 90 ]
    Days in hospital

  17. NAD levels [ Time Frame: Day 1 ]
    Measurements of NAD+ and related metabolite levels by mass spectrometry in whole blood.

  18. NAD levels [ Time Frame: Day 7 ]
    Measurements of NAD+ and related metabolite levels by mass spectrometry in whole blood.

  19. NAD levels [ Time Frame: Day 14 ]
    Measurements of NAD+ and related metabolite levels by mass spectrometry in whole blood.

  20. NAD levels [ Time Frame: Day 90 ]
    Measurements of NAD+ and related metabolite levels by mass spectrometry in whole blood.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. Age 70 or older, inclusive at the time of diagnosis.
  3. Body mass index between 18-40 kg/m2 (both inclusive) and weight ≥ 40 kg at enrolment.
  4. A diagnosis of Covid-19.

Exclusion Criteria:

  1. Need for oxygen therapy.
  2. Ongoing severe acute respiratory syndrome.
  3. Cancer diagnosis within last 5 years.
  4. Unwillingness or inability to follow the procedures outlined in the protocol.
  5. Concurrent enrollment in another clinical study involving an investigational treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407390


Contacts
Layout table for location contacts
Contact: Morten Scheibye-Knudsen, MD/DMSc(PhD) +4542507060 mscheibye@sund.ku.dk

Locations
Layout table for location information
Denmark
Bispebjerg Hospital Recruiting
Copenhagen NV, Denmark, 2400
Contact: Celeste Porsbjerg, MD/PhD         
Sponsors and Collaborators
University of Copenhagen
Bispebjerg Hospital
Elysium Health
Layout table for additonal information
Responsible Party: Morten Scheibye-Knudsen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04407390    
Other Study ID Numbers: H-20026601
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents