Status:
COMPLETED
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
SARS-CoV-2 Infection
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 nicotinamid...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04818216
Start Date
June 11 2021
End Date
January 3 2022
Last Update
December 26 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
2
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
3
University Health Systems
San Antonio, Texas, United States, 78229
4
Harborview Medical Center
Seattle, Washington, United States, 98104