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Completed

NCT Number: NCT04818216

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo capsule containing inert ingredient

Other names: Microcrystalline cellulose

Nicotinamide riboside

Drug

250 mg Nicotinamide riboside capsules

Other names: Niagen

Primary outcomes

  1. Change in Whole Blood NAD+ Level

    Time frame: Baseline to 10 days

    Measure of NAD+ level in whole blood from treatment beginning to end

  2. Number of Participants With Adverse Events of Grade 3 or Higher

    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.

  3. Occurrence of Thrombocytopenia

    Time frame: Baseline to 10 days

    Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.

Secondary outcomes

  1. Change in Area Under the Curve (AUC)

    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

  2. Effect of NR on Major Adverse Kidney Events (MAKE)

    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.

  3. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 30 days to 90 days

    Measurement of change in eGFR at 30-90 days post randomization

  4. Change in Proteinuria

    Time frame: 30 days to 90 days

    Measurement of change in proteinuria at 30-90 days post randomization

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection

Acronym: NIRVANA

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Dec 26, 2023

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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