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Effects of Nicotinamide Riboside on the Clinical Outcome of Covid-19 in the Elderly
Plain-language guide to NCT04407390: phase 2 randomized trial of NAD+. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04407390
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2020-06-01
- Completion (planned or actual)
- 2021-05-01
- Participants
- n/a (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- COVID
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around NAD+.
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.
It had two arms (groups): Control (placebo comparator) and NR (experimental).
Patients receiving placebo.
Patients receiving nicotinamide riboside (NR-E).
The registry classes the interventions as dietary supplement.
More on the Plan
Given the highly infectious virus and the relatively high mortality, this pandemic will likely result in many thousand casualties.
The elderly population is particularly problematic because long term respirator use for these patients is connected with a substantial mortality risk.
Many organisms including humans cannot produce nicotinamide riboside but have evolved methods to convert this into the central redox modulator NAD+.
No treatment-emergent adverse events have so far been reported for nicotinamide riboside 1.3 Rationale NAD+ is emerging as a central metabolic molecule involved in multiple age-related pathways including inflammation and metabolic control.
Who Took Part
It was open to people of any sex aged from 70 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: need for oxygen therapy; ongoing severe acute respiratory syndrome; cancer diagnosis within last 5 years.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2020-06-01 with completion listed for 2021-05-01.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Hypoxic respiratory failure (time frame: Day 1). Hypoxic respiratory failure (time frame: Day 7). Hypoxic respiratory failure (time frame: Day 14).
It also tracked 20 secondary outcomes, for example Mortality, Mortality, Mortality, Mortality, Sepsis and Sepsis.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of NAD+ in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.