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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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
Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3);
Willing to adhere to the study intervention regimen;

Exclusion Criteria

Hypersensitivity to nicotinamide riboside (NR);
Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;
eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab;
Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization
Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed);
Concomitant cirrhosis of liver or acute liver failure;
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;
Individuals with kidney transplant;
Individuals with blood platelet count <100,000/microL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Placebo capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide Riboside Group	Nicotinamide riboside	Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days

Primary Outcome Measures

Name	Time	Method
Change in Whole Blood NAD+ Level	Baseline to 10 days	Measure of NAD+ level in whole blood from treatment beginning to end
Number of Participants With Adverse Events of Grade 3 or Higher	Baseline to 10 days	Safety of NR in hospitalized patients with COVID-19 and AKI (defined as adverse event of Grade 3 or higher). Not every grade 3 event was considered to be serious.
Occurrence of Thrombocytopenia	Baseline to 10 days	Number occurrences of thrombocytopenia defined as \>25% decline in blood platelet count from baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Estimated Glomerular Filtration Rate (eGFR)	30 days to 90 days	Measurement of change in eGFR at 30-90 days post randomization
Change in Area Under the Curve (AUC)	Baseline to 10 days	To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Effect of NR on Major Adverse Kidney Events (MAKE)	30 days to 90 days	Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.
Change in Proteinuria	30 days to 90 days	Measurement of change in proteinuria at 30-90 days post randomization

Locations (4): Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
University Health Systems
🇺🇸
San Antonio, Texas, United States
The University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Harborview Medical Center
🇺🇸
Seattle, Washington, United States