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MIB-626 for Coronavirus

Phase 2

Waitlist Available

Led By Shalender Bhasin, MD

Research Sponsored by Metro International Biotech, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial tests if MIB-626 can help adults with COVID-19 and early-stage kidney problems by protecting their kidney function and reducing inflammation.

Eligible Conditions

Acute Kidney Injury
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 14 days or hospital discharge, or death, whichever comes first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in serum cystatin C levels

Secondary study objectives

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 markers of endothelial damage (vWF, VCAM, PAI-1)

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

+7 more

Other study objectives

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

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

The WHO 8-point Ordinal Scale of Clinical Status

+5 more

Side effects data

From 2022 Phase 2 trial • 7 Patients • NCT04817111

14%

Constipation

14%

Belching

14%

Back pain

14%

Neck pain

14%

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Open Label - MIB-626

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: MIB-626Experimental Treatment1 Intervention

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.

Group II: Home TreatmentExperimental Treatment3 Interventions

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.

Group III: Placebo TabletPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MIB-626

2021

Completed Phase 2

~50

Placebo

1995

Completed Phase 3

~2670