Clinical trial NCT04818216: Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Official title: NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection
Acute Kidney Injury
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind, placebo-controlled clinical interventional trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Whole Blood NAD+ Level
timeFrame: Baseline to 10 days
measure: Number of Participants With Adverse Events of Grade 3 or Higher
timeFrame: Baseline to 10 days
measure: Occurrence of Thrombocytopenia
timeFrame: Baseline to 10 days
Secondary outcomes:
measure: Change in Area Under the Curve (AUC)
timeFrame: Baseline to 10 days
measure: Effect of NR on Major Adverse Kidney Events (MAKE)
timeFrame: 30 days to 90 days
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: 30 days to 90 days
measure: Change in Proteinuria
timeFrame: 30 days to 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: University Health Systems
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: UT Health San Antonio
name: Kumar Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: