Phase 2a MIB-626 vs. Placebo COVID-19

NCT05038488 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MIB-626-202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 response to the infection.

Conditions

Covid19; Stage 1 Acute Kidney Injury

Keywords

MIB-626; Covid19; Early Acute Kidney Injury; NAD-boosting drug

Outcome Measures

Primary Outcomes (1)

• Change from baseline in serum cystatin C levels

  Change from baseline in serum cystatin C levels

  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)

  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)

  enrollment to 14 days or hospital discharge, or death, whichever comes first

• Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)

  enrollment to 14 days or hospital discharge, or death, whichever comes first

• Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)

  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

  enrollment to 14 days or hospital discharge, or death, whichever comes first

Other Outcomes (8)

• Progression in the stage of acute kidney injury increase in serum creatinine OR serum creatinine > 4.0 mg/dL OR need

  enrollment to 14 days or hospital discharge, or death, whichever comes first

• The WHO 8-point Ordinal Scale of Clinical Status

  enrollment to 14 days or hospital discharge, or death, whichever comes first

• Change from baseline in Modified Sequential Organ Failure Assessment (SOFA) Score (SOFA) Score

  enrollment to 14 days or hospital discharge, or death, whichever comes first

Study Arms (3)

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.

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.

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.

Drug: MIB-626; Drug: Placebo; Other: Home Treatment

Interventions

MIB-626 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.

Also known as: NAD-boosting drug

Home Treatment; MIB-626

Placebo DRUG

Subjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally.

Home Treatment; Placebo Tablet

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.

Home Treatment

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Metro International Biotech, LLC: lead

Study Sites (1)

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 40746868 DERIVED

MeSH Terms

Conditions

COVID-19; Acute Kidney Injury

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

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: September 9, 2021
• Study Start: October 26, 2021
• Primary Completion: August 17, 2023
• Study Completion: August 17, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)