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

Phase 2

• Conditions: COVID-19; ARDS, Human; Stem Cells; Regeneration
• Interventions: Drug: Placebo; Drug: MRG-001

• Registration Number: NCT04646603
• Lead Sponsor: MedRegen LLC

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-11-30
• Study Start: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-30
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-03-31
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single SC dose of 0.0066 mL/kg Sterile Injectable Saline (n=20) will be administered every other day for the duration of 13 days totaling 7 injections.
MRG-001	MRG-001	Multiple SC dose of 0.0066 mL/kg MRG-001 (n=20) will be administered every other day for the duration of 13 days totaling 7 injections.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	60 days	To evaluate the safety (SAE's) of MRG-001 in Severe and Critical SARS-CoV-2 patients.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ALT, AST, INR, Albumin, Bilirubin, LDH, BUN, eGFR	15 days
Change in Plerixafor concentration (ng/ml) from baseline in blood	15 days
Change in percentages from baseline in circulating white blood cell subpopulations	15 days
Change in Tacrolimus concentration (ng/ml) from baseline in blood	15 days
Change in percentages from baseline in circulating stem cells and immune cells	15 days
Time to clinical improvement from randomization by at least 2 points on the 8-point ordinal scale of WHO clinical improvement scale assessed up to 14 and 60 days (1=Asymptomatic, no limitations of activities; 8=death).	60 days
All-cause mortality assessed at 14, 28 and 60 days following randomization.	60 days

Trial Locations

Locations (1)

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States