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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Acute Kidney Injury; SARS-CoV-2 Infection

Treatments: Drug: Placebo; Drug: Nicotinamide riboside

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04818216

3UH3DK114920-04S2 (U.S. NIH Grant/Contract)

HSC20200914H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo capsules will be administered 2 capsules twice daily for 10 days

Treatment:

Drug: Placebo

Nicotinamide Riboside Group

Experimental group

Description:

Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days

Treatment:

Drug: Nicotinamide riboside