Covid19Phase 2NCT05038488
Phase 2a MIB-626 vs. Placebo COVID-19
A Phase 2 study testing MIB-626 and Home Treatment in people with Covid19 and Stage 1 Acute Kidney Injury, run by Metro International Biotech, LLC at 1 site in United States.
Trial summary
The proposed phase 2a trial will determine whether MIB-626 treatment in adults with COVID-19 infection and stage 1 acute kidney injury is more efficacious than placebo in preventing worsening of kidney function, as assessed by longitudinal changes in serum creatinine concentration, and in attenuating the inflammatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Stage 1 Acute Kidney Injury
- What is being tested?
- MIB-626 and Home Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 17 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- A man or a woman, 18 years or older
- Willing and able to provide informed consent, or with a legal representative who can provide informed consent with participant's assent
- Has Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by an approved diagnostic test before randomization
- Currently hospitalized
- Documented increase in serum creatinine of 0.3 mg/dL or 50%-99% over baseline (baseline either based on admission serum creatinine or known pre-admission baseline, defined as most recent previous measurement)
- Participant or legal representative has read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained
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- Is willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA)
- Patients who are receiving remdesivir as a part of their clinical care or are in clinical trials of remdesivir or other antiviral drugs may be allowed if they meet other eligibility criteria
- Patients, who are participating in observational studies or studies of nonpharmacological interventions, will be allowed to participate
- Not be pregnant and not planning to become pregnant over the next 6 months
Who cannot join
- In the intensive care unit at the time of screening or prior to randomization
- Requiring mechanical ventilation at the time of screening or prior to randomization
- Has baseline estimated glomerular filtration rate < 30 ml/min/1.73m2
- Has a history of kidney transplantation or hemodialysis treatment or receiving or expected to receive hemodialysis or peritoneal dialysis at screening and prior to randomization
- Is on mechanical ventilation
- Has a contraindication for MIB-626 or its inert ingredients
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- Has a diagnosis of lupus nephritis, polycystic kidney disease, other glomerular disease (other than diabetes)
- Has AST or ALT > 3 times the upper limit of normal
- Has other medical condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results
- Will exclude patients, who are receiving or are enrolled in placebo-controlled intervention trials of anti-inflammatory or immunomodulatory agents, such as tocilizumab. Occasional use of acetaminophen and nonsteroidal anti-inflammatory drugs, such as ibuprofen, for fever or headache is permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase 2a Randomized Controlled Trial of MIB-626 (NAD-boosting Drug) vs. Placebo in Adults With COVID-19 Infection and Early Acute Kidney Injury
The proposed phase 2a trial will determine whether MIB-626 treatment in adults with COVID-19 infection and stage 1 acute kidney injury is more efficacious than placebo in preventing worsening of kidney function, as assessed by longitudinal changes in serum creatinine concentration, and in attenuating the inflammatory response to the infection.
Read the detailed description
This is a two-center, randomized, double-blind, placebo-controlled, parallel-group, phase 2a study that will determine the efficacy and safety of MIB-626 treatment relative to placebo in adult patients with COVID-19 infection and stage 1 acute kidney injury.
Hospitalized adult patients with a confirmed or suspected diagnosis of COVID-19 infection will be screened for conformity to inclusion and exclusion criteria and those meeting eligibility criteria on screening will be offered participation in the study. Fifty participants, who meet all the eligibility criteria, and are able and willing to provide informed consent, will be randomized, stratified by sex, remdesivir use, and trial site, in a 3:2 ratio to receive either MIB-626 1.0 g orally or matching placebo twice daily for 14 days. The participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period.
- Conditions
- Covid19, Stage 1 Acute Kidney Injury
- Being tested
- MIB-626, Placebo, Home Treatment
- Keywords
- MIB-626, Covid19, Early Acute Kidney Injury, NAD-boosting drug
- 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.
MIB-626Drug
Also called NAD-boosting drug
Fifty participants will be randomized, stratified by sex, remdesivir use, and trial site, in a 3:2 ratio to receive either MIB-626 1.0 g orally or matching placebo twice daily for 14 days.
PlaceboDrug
Subjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally.
Home TreatmentOther
Participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period.
| Study group | Role | What they receive |
|---|---|---|
| MIB-626 | Experimental | Oral administration of MIB-626 substantially raises the intracellular NAD+ levels and activates signaling mechanisms that regulate inflammation and cell survival, downregulates the NLRP3 inflammasome, and attenuates the inflammatory response in a number of experimental models, and protects against tissue damage induced by pro-inflammatory cytokines. Receives: Drug: MIB-626 |
| Placebo Tablet | Placebo comparator | A placebo control will be supplied. Participants randomized to placebo will receive matching tablet.
Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. Receives: Drug: Placebo |
| Home Treatment | Other | Participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period. Receives: Drug: MIB-626; Drug: Placebo; Other: Home Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum cystatin C levels
Change from baseline in serum cystatin C levels
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Secondary outcomes (10)
Change from baseline to peak concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
Change from baseline to peak concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
The trajectory of change from baseline in concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
The trajectory of change from baseline in concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
The trajectory of change in plasma (NGAL, KIM-1) and urinary (KIM-1, NGAL, albumin) biomarkers of acute kidney injury
The trajectory of change in plasma (NGAL, KIM-1) and urinary (KIM-1, NGAL, albumin) biomarkers of acute kidney injury
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
Change in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in oxygen saturation
Change from baseline in oxygen saturation
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change in high sensitivity troponin-1 concentration from enrollment to peak during hospitalization (measured daily in stored biospecimens)
Change in high sensitivity troponin-1 concentration from enrollment to peak during hospitalization (measured daily in stored biospecimens)
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in intracellular NAD+ concentrations in blood during the 14-day treatment period in a subset of study participants
Change from baseline in intracellular NAD+ concentrations in blood during the 14-day treatment period in a subset of study participants
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Circulating concentrations of MIB-626 and its key metabolites P2Y, NAAD, NAM, 1-methylnicotinamide during the 14-day treatment period
Circulating concentrations of MIB-626 and its key metabolites P2Y, NAAD, NAM, 1-methylnicotinamide during the 14-day treatment period
Measured: enrollment to 14 days or hospital discharge, or death, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start26 Oct 2021
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- This will be a two center, randomized, double-blind, placebo- controlled, parallel group, efficacy trial to determine the efficacy of MIB-626 treatment relative to placebo in adult patients with COVID-19 infection and stage 1 acute kidney injury. Participants will be screened for eligibility and those meeting eligibility criteria will be offered participation in the study. The subjects will be randomized by minimization to receive MIB-626 or placebo twice daily for up to 14 days. The participants will be followed for 28 days after the administration of the last dose of the investigational product. Kidney function will be ascertained by daily measurements of serum creatinine, which is the standard of care in hospitalized patients with COVID-19.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metro International Biotech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Shalender Bhasin, Metro International Biotech, LLC
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038488
- Sponsor's protocol ID
- MIB-626-202
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Publications
Pencina KM, Leaf DE, Valderrabano RJ, Waikar SS, Mehta TS, Shang YV, Latham NK, John T, Volpi E, Fusco D, Memish-Beleva Y, Krishnamurthy S, Lavu S, Karmi S, Livingston DJ, Bhasin S. Oral MIB-626 (beta Nicotinamide Mononucleotide) Safely Raises Blood Nicotinamide Adenine Dinucleotide Levels in Hospitalized Patients With COVID-19 and Acute Kidney Injury: A Randomized Controlled Trial. FASEB Bioadv. 2025 Jun 18;7(8):e70011. doi: 10.1096/fba.2025-00014. eCollection 2025 Aug.
PubMed 40746868
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized Controlled Trial of MIB-626 (NAD-boosting Drug) vs. Placebo in Adults With COVID-19 Infection and Early Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05038488
- Acronym / sponsor ID
- MIB-626-202
- Conditions
- Covid19, Stage 1 Acute Kidney Injury
- Keywords
- MIB-626, Covid19, Early Acute Kidney Injury, NAD-boosting drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Metro International Biotech, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed phase 2a trial will determine whether MIB-626 treatment in adults with COVID-19 infection and stage 1 acute kidney injury is more efficacious than placebo in preventing worsening of kidney function, as assessed by longitudinal changes in serum creatinine concentration, and in attenuating the inflammatory response to the infection.
Detailed description
This is a two-center, randomized, double-blind, placebo-controlled, parallel-group, phase 2a study that will determine the efficacy and safety of MIB-626 treatment relative to placebo in adult patients with COVID-19 infection and stage 1 acute kidney injury.
Hospitalized adult patients with a confirmed or suspected diagnosis of COVID-19 infection will be screened for conformity to inclusion and exclusion criteria and those meeting eligibility criteria on screening will be offered participation in the study. Fifty participants, who meet all the eligibility criteria, and are able and willing to provide informed consent, will be randomized, stratified by sex, remdesivir use, and trial site, in a 3:2 ratio to receive either MIB-626 1.0 g orally or matching placebo twice daily for 14 days. The participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a two center, randomized, double-blind, placebo- controlled, parallel group, efficacy trial to determine the efficacy of MIB-626 treatment relative to placebo in adult patients with COVID-19 infection and stage 1 acute kidney injury. Participants will be screened for eligibility and those meeting eligibility criteria will be offered participation in the study. The subjects will be randomized by minimization to receive MIB-626 or placebo twice daily for up to 14 days. The participants will be followed for 28 days after the administration of the last dose of the investigational product. Kidney function will be ascertained by daily measurements of serum creatinine, which is the standard of care in hospitalized patients with COVID-19.
| Arm | Type | Receives |
|---|---|---|
| MIB-626 | Experimental | Drug: MIB-626Oral administration of MIB-626 substantially raises the intracellular NAD+ levels and activates signaling mechanisms that regulate inflammation and cell survival, downregulates the NLRP3 inflammasome, and attenuates the inflammatory response in a number of experimental models, and protects against tissue damage induced by pro-inflammatory cytokines. |
| Placebo Tablet | Placebo comparator | Drug: PlaceboA placebo control will be supplied. Participants randomized to placebo will receive matching tablet. Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. |
| Home Treatment | Other | Drug: MIB-626, Drug: Placebo, Other: Home TreatmentParticipants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A man or a woman, 18 years or older
- Willing and able to provide informed consent, or with a legal representative who can provide informed consent with participant's assent
- Has Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by an approved diagnostic test before randomization
- Currently hospitalized
- Documented increase in serum creatinine of 0.3 mg/dL or 50%-99% over baseline (baseline either based on admission serum creatinine or known pre-admission baseline, defined as most recent previous measurement)
Key exclusion criteria (10 listed)
- In the intensive care unit at the time of screening or prior to randomization
- Requiring mechanical ventilation at the time of screening or prior to randomization
- Has baseline estimated glomerular filtration rate < 30 ml/min/1.73m2
- Has a history of kidney transplantation or hemodialysis treatment or receiving or expected to receive hemodialysis or peritoneal dialysis at screening and prior to randomization
- Is on mechanical ventilation
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 |
|---|---|---|
| MIB-626Also: NAD-boosting drugFifty participants will be randomized, stratified by sex, remdesivir use, and trial site, in a 3:2 ratio to receive either MIB-626 1.0 g orally or matching placebo twice daily for 14 days. | Drug | Home Treatment, MIB-626 |
| PlaceboSubjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally. | Drug | Home Treatment, Placebo Tablet |
| Home TreatmentParticipants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period. | Other | Home Treatment |
Primary outcome
Change from baseline in serum cystatin C levels
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in serum cystatin C levels
10 secondary outcomes
Change from baseline to peak concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The trajectory of change from baseline in concentrations of inflammatory biomarkers (IL6, TNF-alpha, hsCRP, Angiotensin 2 to Angiotensin1, 7 ratio, ACE 2)
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The trajectory of change in plasma (NGAL, KIM-1) and urinary (KIM-1, NGAL, albumin) biomarkers of acute kidney injury
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in oxygen saturation
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change in high sensitivity troponin-1 concentration from enrollment to peak during hospitalization (measured daily in stored biospecimens)
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in intracellular NAD+ concentrations in blood during the 14-day treatment period in a subset of study participants
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Circulating concentrations of MIB-626 and its key metabolites P2Y, NAAD, NAM, 1-methylnicotinamide during the 14-day treatment period
Time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 40746868Pencina KM, Leaf DE, Valderrabano RJ, Waikar SS, Mehta TS, Shang YV, Latham NK, John T, Volpi E, Fusco D, Memish-Beleva Y, Krishnamurthy S, Lavu S, Karmi S, Livingston DJ, Bhasin S. Oral MIB-626 (beta Nicotinamide Mononucleotide) Safely Raises Blood Nicotinamide Adenine Dinucleotide Levels in Hospitalized Patients With COVID-19 and Acute Kidney Injury: A Randomized Controlled Trial. FASEB Bioadv. 2025 Jun 18;7(8):e70011. doi: 10.1096/fba.2025-00014. eCollection 2025 Aug.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIB-626 and Home Treatment in people with Covid19 and Stage 1 Acute Kidney Injury, run by Metro International Biotech, LLC at 1 site 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 10 inclusion and 10 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in serum cystatin C levels (time frame: enrollment to 14 days or hospital discharge, or death, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038488, which also lists 1 linked publication.
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 27 Aug 2024.