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MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients | Clinical Trials | Clareo Health

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MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients

A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study in Hospitalized Patients Infected With Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

NCT04646603•MedRegen LLC

View on ClinicalTrials.gov

Summary

This study consists of two parts. Part A (Phase I): A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assess the Safety, Pharmacokinetics, Pharmacodynamics of MRG-001 Part B (Phase 2): A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Study in Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Detailed Description

MRG-001 is a fixed-dose combination (FDC) drug, administered as a single subcutaneous (SC) injection. Preclinical studies have demonstrated a synergistic effect of these 2 APIs in mobilizing and recruiting stem cells/immunoregulatory cells and promoting tissue regeneration in a wide variety of studies. MRG-001 is likely to target multiple aspects of the COVID-19. MRG-001 exhibits immunoregulatory and regenerative properties in preclinical studies with a wide variety of diseases. Repairing damaged tissues in the lung and other organs, restoring the anti-virus immune system and modulating the inflammation are obvious therapeutic targets for COVID-19. Part A has been completed in May 01, 2021. Part B has been initiated in January 2022.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject voluntarily agrees to participate in this study and is able to provide written informed consent or has a legal representative who can provide informed consent.
•2. Males and females over 18 years of age, inclusive, at the time of signing the ICF.
•3. Hospitalized, with COVID-19 symptoms of respiratory illness caused by SARS-CoV-2 infection (defined as Scale 5 - 7 on the WHO 8-point ordinal scale for clinical improvement.
•4. Laboratory-confirmation SARS-CoV-2 by real time polymerase chain reaction in the respiratory tract (NP swab, oropharyngeal swab, tracheal aspirate, BAL) \</=14 days prior to randomization.
•5. Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection.
•6. Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period from the screening visit until the end of study visit.
•7. Men must be willing to use a double-barrier contraception from enrollment until at 5 months after the last dose of study drug, if not abstinent.

Exclusion Criteria

•1\. Participation in any other clinical trial of an experimental treatment for COVID-19 (remdesivir use is permitted).
•2\. Significant pre-existing organ dysfunction prior to randomization
•1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record
•2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record. clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \>180 mm Hg and diastolic blood pressure \>110 mm Hg.
•3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR \<30 mL/min
•4. Liver: Severe chronic liver disease defined as Child-Pugh Class C
•5. Hematologic: Baseline platelet count \<50,000/mm3
•2\. Concurrent treatment or prior use of drugs with actual or possible direct acting immunomodulatory activity against ARDS in COVID-19 is prohibited including JAK1/JAK2 inhibitor ruxolitinib, baricitinib and tofacitinib. However, IL-6 inhibitors such as tocilizumab, sarilumab are allowed if given \>72 hours prior to first study dose. Corticosteroids are permitted throughout the study.
•3\. History of splenectomy or splenomegaly (spleen weighing \>750 g).
•4\. Body mass index of \>45 kg/m2 at screening
+17 more criteria

Locations (1)

Johns Hopkins Medicine

Baltimore, Maryland, United States

Key Dates

Start Date

December 1, 2021

Primary Completion Date

March 31, 2022

Completion Date

July 1, 2022

Last Updated

February 15, 2022

Enrollment

ESTIMATED participants

Conditions

COVID-19ARDS, HumanStem CellsRegeneration

Interventions

MRG-001

DRUG

Placebo

DRUG

Contacts

Ali R Ahmadi, MD PhD

CONTACT

+14437598563 info@medregenco.com

James Burdick, MD

CONTACT

+14437598563 info@medregenco.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients

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