Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection

Purpose

An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized patients with COVID-19 infection and acute kidney injury to determine the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use of NR.

Conditions

  • SARS-CoV-2 Infection
  • Acute Kidney Injury

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR); 2. Male or female, >18 years old; 3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection 4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3); 5. Willing to adhere to the study intervention regimen;

Exclusion Criteria

  1. Hypersensitivity to nicotinamide riboside (NR); 2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements; 3. eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab; 4. Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization 5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed); 6. Concomitant cirrhosis of liver or acute liver failure; 7. Any medical history or condition that might, in the opinion of the attending physician, put the participant at significant risk if he/she were to participate in the trial; 8. Individuals with kidney transplant; 9. Individuals with blood platelet count <100,000/microL

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Prospective, double-blind, placebo-controlled clinical interventional trial
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo Group 		Placebo capsules will be administered 2 capsules twice daily for 10 days
  • Drug: Placebo
    Placebo capsule containing inert ingredient
    Other names:
    • Microcrystalline cellulose
Experimental
Nicotinamide Riboside Group 		Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
  • Drug: Nicotinamide riboside
    250 mg Nicotinamide riboside capsules
    Other names:
    • Niagen

Recruiting Locations

More Details

NCT ID
NCT04818216
Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Detailed Description

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. The study team will evaluate whole blood NAD+ levels as a marker of efficacy and biological effect of NR.