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

NCT04818216 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: HSC20200914H3UH3DK114920-04S2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

SARS-CoV-2 Infection; Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

• Change in Whole Blood NAD+ Level

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

  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.

  Baseline to 10 days

• Occurrence of Thrombocytopenia

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

  Baseline to 10 days

Secondary Outcomes (4)

• Change in Area Under the Curve (AUC)

  Baseline to 10 days

• Effect of NR on Major Adverse Kidney Events (MAKE)

  30 days to 90 days

• Change in Estimated Glomerular Filtration Rate (eGFR)

  30 days to 90 days

• Change in Proteinuria

  30 days to 90 days

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Placebo capsules will be administered 2 capsules twice daily for 10 days

Drug: Placebo

Nicotinamide Riboside Group

EXPERIMENTAL

Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days

Drug: Nicotinamide riboside

Interventions

Placebo DRUG

Placebo capsule containing inert ingredient

Also known as: Microcrystalline cellulose

Placebo Group

Nicotinamide riboside DRUG

250 mg Nicotinamide riboside capsules

Also known as: Niagen

Nicotinamide Riboside Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University Health Systems

San Antonio, Texas, 78229, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

COVID-19; Acute Kidney Injury

Interventions

microcrystalline cellulose; nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Subrata Debnath, Assistant Professor
• Organization: University of Texas Health San Antonio

nath@uthscsa.edu

210-450-8333

Study Officials

• Kumar Sharma, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Holder of the L. David Hillis, M.D. Endowed Chair, Medicine -Renal Diseases

Model Details: Prospective, double-blind, placebo-controlled clinical interventional trial

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: June 11, 2021
• Primary Completion: December 9, 2021
• Study Completion: January 3, 2022
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time when summary data are published or otherwise made available

Locations

US (4)