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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
+5 more other outcomes

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

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: 40746868DERIVED

MeSH Terms

Conditions

COVID-19Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRenal InsufficiencyKidney Diseases

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

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.

Sponsor Type

INDUSTRY

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Other Outcomes (8)

Study Arms (3)

MIB-626

Placebo Tablet

Home Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Other Outcomes (8)

Study Arms (3)

MIB-626

Placebo Tablet

Home Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations