Effects of Nicotinamide Riboside on the Clinical Outcome of Covid-19 in the Elderly

NCT04407390 | Withdrawn Phase 2 DMC

• 1 other identifier: H-20026601
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (4)

• Hypoxic respiratory failure

  Hypoxic respiratory failure as defined by need for oxygen therapy

  Day 1

• Hypoxic respiratory failure

  Hypoxic respiratory failure as defined by need for oxygen therapy

  Day 7

• Hypoxic respiratory failure

  Hypoxic respiratory failure as defined by need for oxygen therapy

  Day 14

• Hypoxic respiratory failure

  Hypoxic respiratory failure as defined by need for oxygen therapy

  Day 90

Secondary Outcomes (20)

• Mortality

  Day 1

• Mortality

  Day 7

• Mortality

  Day 14

• Mortality

  Day 90

• Sepsis

  Day 1

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients receiving placebo.

Dietary Supplement: Placebo

NR

EXPERIMENTAL

Patients receiving nicotinamide riboside (NR-E)

Dietary Supplement: Nicotinamide riboside

Interventions

Nicotinamide riboside DIETARY_SUPPLEMENT

The patients will receive 1 g of nicotinamide riboside or placebo orally every morning for 14 days.

NR

Placebo DIETARY_SUPPLEMENT

Placebo

Control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Bispebjerg Hospital: collaborator
• Elysium Health: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized double-blind case-control trial

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

DK (1)