SARS-CoV-2 InfectionPhase 2NIRVANANCT04818216
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
A Phase 2 study testing Nicotinamide riboside in people with SARS-CoV-2 Infection and Acute Kidney Injury, run by The University of Texas Health Science Center at San Antonio at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Acute Kidney Injury
- What is being tested?
- Nicotinamide riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jun 2021to 3 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University Health Systems
San Antonio, Texas, 78229
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: NIRVANA: NIcotinamide Riboside in SARS-CoV-2 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.
Read the 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 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
- SARS-CoV-2 Infection, Acute Kidney Injury
- Being tested
- Placebo, Nicotinamide riboside
- Medical subject headings
- COVID-19, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Microcrystalline cellulose
Placebo capsule containing inert ingredient
Nicotinamide ribosideDrug
Also called Niagen
250 mg Nicotinamide riboside capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo capsules will be administered 2 capsules twice daily for 10 days Receives: Drug: Placebo |
| Nicotinamide Riboside Group | Experimental | Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days Receives: Drug: Nicotinamide riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Whole Blood NAD+ Level
Measure of NAD+ level in whole blood from treatment beginning to end
Measured: 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.
Measured: Baseline to 10 days
Occurrence of Thrombocytopenia
Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.
Measured: Baseline to 10 days
Secondary outcomes (4)
Change in Area Under the Curve (AUC)
To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention
Measured: Baseline to 10 days
Effect of NR on Major Adverse Kidney Events (MAKE)
Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.
Measured: 30 days to 90 days
Change in Estimated Glomerular Filtration Rate (eGFR)
Measurement of change in eGFR at 30-90 days post randomization
Measured: 30 days to 90 days
Change in Proteinuria
Measurement of change in proteinuria at 30-90 days post randomization
Measured: 30 days to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start11 Jun 2021
- Primary completion9 Dec 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-blind, placebo-controlled clinical interventional trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kumar Sharma, The University of Texas Health Science Center at San Antonio
- Investigators
- Kumar Sharma, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818216
- Sponsor's protocol ID
- HSC20200914H
- Other IDs
- 3UH3DK114920-04S2
- Acronym
- NIRVANA
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2021
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRVANA: NIcotinamide Riboside in SARS-CoV-2 pAtients for reNAl Protection
- ClinicalTrials.gov ID
- NCT04818216
- Acronym / sponsor ID
- NIRVANA / HSC20200914H
- Conditions
- SARS-CoV-2 Infection, Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blind, placebo-controlled clinical interventional trial
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo capsules will be administered 2 capsules twice daily for 10 days |
| Nicotinamide Riboside Group | Experimental | Drug: Nicotinamide ribosideNicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Microcrystalline cellulosePlacebo capsule containing inert ingredient | Drug | Placebo Group |
| Nicotinamide ribosideAlso: Niagen250 mg Nicotinamide riboside capsules | Drug | Nicotinamide Riboside Group |
Primary outcome
Change in Whole Blood NAD+ Level
Time frame: Baseline to 10 days
Measure of NAD+ level in whole blood from treatment beginning to end
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.
Occurrence of Thrombocytopenia
Time frame: Baseline to 10 days
Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline.
4 secondary outcomes
Change in Area Under the Curve (AUC)
Time frame: Baseline to 10 days
Effect of NR on Major Adverse Kidney Events (MAKE)
Time frame: 30 days to 90 days
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: 30 days to 90 days
Change in Proteinuria
Time frame: 30 days to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kumar Sharma, MD principal investigator
The University of Texas Health Science Center at San Antonio
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide riboside in people with SARS-CoV-2 Infection and Acute Kidney Injury, run by The University of Texas Health Science Center at San Antonio at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Whole Blood NAD+ Level (time frame: Baseline to 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.