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

NCT ID: NCT04818216

Last Updated: 2023-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2022-01-03

Brief Summary

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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

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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.

Conditions

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SARS-CoV-2 Infection Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, double-blind, placebo-controlled clinical interventional trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.

Study Groups

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Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule containing inert ingredient

Nicotinamide Riboside Group

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

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

250 mg Nicotinamide riboside capsules

Interventions

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Placebo

Placebo capsule containing inert ingredient

Intervention Type DRUG

Nicotinamide riboside

250 mg Nicotinamide riboside capsules

Intervention Type DRUG

Other Intervention Names

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Microcrystalline cellulose Niagen

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR);
2. Male or female, \>18 years old;
3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection
4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3);
5. Willing to adhere to the study intervention regimen;

Exclusion Criteria

1. Hypersensitivity to nicotinamide riboside (NR);
2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;
3. eGFR \<15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab;
4. Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization
5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed);
6. Concomitant cirrhosis of liver or acute liver failure;
7. 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;
8. Individuals with kidney transplant;
9. Individuals with blood platelet count \<100,000/microL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Kumar Sharma

Holder of the L. David Hillis, M.D. Endowed Chair, Medicine -Renal Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kumar Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

University Health Systems

San Antonio, Texas, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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3UH3DK114920-04S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20200914H

Identifier Type: -

Identifier Source: org_study_id