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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Placebo capsule containing inert ingredient
250 mg Nicotinamide riboside capsules
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University Health Systems
San Antonio, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Change in Whole Blood NAD+ Level
Measure of NAD+ level in whole blood from treatment beginning to end
Time frame: Baseline to 10 days
Number of Participants With Adverse Events of Grade 3 or Higher
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.
Time frame: Baseline to 10 days
Occurrence of Thrombocytopenia
Number occurrences of thrombocytopenia defined as \>25% decline in blood platelet count from baseline.
Time frame: Baseline to 10 days
Change in Area Under the Curve (AUC)
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Time frame: Baseline to 10 days
Effect of NR on Major Adverse Kidney Events (MAKE)
Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.
Time frame: 30 days to 90 days
Change in Estimated Glomerular Filtration Rate (eGFR)
Measurement of change in eGFR at 30-90 days post randomization
Time frame: 30 days to 90 days
Change in Proteinuria
Measurement of change in proteinuria at 30-90 days post randomization
Time frame: 30 days to 90 days
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