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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

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