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 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 from baseline in ALT, AST, INR, Albumin, Bilirubin, LDH, BUN, eGFR	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