Placebo
DrugPlacebo capsule containing inert ingredient
Other names: Microcrystalline cellulose
NCT Number: NCT04818216
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Icahn School of Medicine at Mount Sinai, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo capsule containing inert ingredient
Other names: Microcrystalline cellulose
250 mg Nicotinamide riboside capsules
Other names: Niagen
Time frame: Baseline to 10 days
Measure of NAD+ level in whole blood from treatment beginning to end
Time frame: 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.
Time frame: Baseline to 10 days
Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.
Time frame: Baseline to 10 days
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Time frame: 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.
Time frame: 30 days to 90 days
Measurement of change in eGFR at 30-90 days post randomization
Time frame: 30 days to 90 days
Measurement of change in proteinuria at 30-90 days post randomization
The University of Texas Health Science Center at San Antonio
Other
NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
Acronym: NIRVANA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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