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

August 14, 2024 updated by: Shalender Bhasin, Metro International Biotech, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • The Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MIB-626
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
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.
Other Names:
  • NAD-boosting drug
Placebo Comparator: Placebo Tablet

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
Subjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally.
Other: Home Treatment
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
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.
Other Names:
  • NAD-boosting drug
Drug: Placebo
Subjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally.
Other: Home Treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
enrollment to 14 days or hospital discharge, or death, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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)
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 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)
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)
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
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
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 in urinary albumin concentration (normalized to urine creatinine) from enrollment to peak during hospitalization
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 from baseline in oxygen saturation
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 in high sensitivity troponin-1 concentration from enrollment to peak during hospitalization (measured daily in stored biospecimens)
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
Change from baseline in intracellular NAD+ concentrations in blood during the 14-day treatment period in a subset of study participants
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
Circulating concentrations of MIB-626 and its key metabolites P2Y, NAAD, NAM, 1-methylnicotinamide during the 14-day treatment period
enrollment to 14 days or hospital discharge, or death, whichever comes first

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression in the stage of acute kidney injury increase in serum creatinine OR serum creatinine > 4.0 mg/dL OR need
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Progression in the stage of acute kidney injury
enrollment to 14 days or hospital discharge, or death, whichever comes first
The WHO 8-point Ordinal Scale of Clinical Status
Time Frame: 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
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
Change from baseline in Modified Sequential Organ Failure Assessment (SOFA) Score
enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients requiring mechanical ventilation, hemodialysis, or transferred to ICU
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients requiring mechanical ventilation, hemodialysis, or transferred to ICU
enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients requiring hemodialysis
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients requiring hemodialysis
enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients who die
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The number and proportion of patients who die
enrollment to 14 days or hospital discharge, or death, whichever comes first
The number of days it takes for the temperature to return to normal (<99F)
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The number of days it takes for the temperature to return to normal (<99F)
enrollment to 14 days or hospital discharge, or death, whichever comes first
The length of hospital stay
Time Frame: enrollment to 14 days or hospital discharge, or death, whichever comes first
The length of hospital stay
enrollment to 14 days or hospital discharge, or death, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Metro International Biotech, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shalender Bhasin, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIB-626-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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