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Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Plain-language guide to NCT04818216: phase 2 randomized trial of NAD+, kidney protection (ckd, diabetic kidney, lupus kidney), 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04818216
- Phase
- phase 2
- Status
- completed
- Start
- 2021-06-11
- Completion (planned or actual)
- 2021-12-09
- Participants
- 28 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- SARS-CoV-2 Infection; Acute Kidney Injury
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested NAD+ for kidney protection (ckd, diabetic kidney, lupus kidney).
It had two arms (groups): Placebo Group (placebo comparator) and Nicotinamide Riboside Group (experimental).
The registry classes the interventions as drug.
More on the Plan
The study team chose a treatment protocol with NR as a treatment for patients who will be admitted with COVID-19 related illness and develop AKI after admission.
Treatment duration will be for 10 days and the primary study endpoint will be the change in whole blood NAD+ from baseline to end of treatment in NR group vs placebo group.
Who Took Part
Enrollment: 28 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR);. Male or female, \>18 years old;. Hospitalized participants with a laboratory diagnosis of COVID-19 infection. Willing to adhere to the study intervention regimen;.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: hypersensitivity to nicotinamide riboside (nr);; pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;; maintenance renal replacement therapy or initiation of renal replacement therapy before randomization.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
Groups ran in parallel: each of the kidney protection (ckd, diabetic kidney, lupus kidney) participants stayed in one arm throughout.
Neither the kidney protection (ckd, diabetic kidney, lupus kidney) participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2021-06-11 with completion listed for 2021-12-09.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in Whole Blood NAD+ Level (time frame: Baseline to 10 days). Number of Participants With Adverse Events of Grade 3 or Higher (time frame: Baseline to 10 days). Occurrence of Thrombocytopenia (time frame: Baseline to 10 days).
It also tracked 4 secondary outcomes, for example Change in Area Under the Curve (AUC), Change in Estimated Glomerular Filtration Rate (eGFR) and Change in Proteinuria.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of NAD+ in 28 people with kidney protection (ckd, diabetic kidney, lupus kidney).
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the NAD+ compound page, Kidney protection (CKD, diabetic kidney, lupus kidney) research.
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.