NCT04646603

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: MedRegen LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• ARDS, Human
• Stem Cells
• Regeneration

Interventions

Type	Name	Description
DRUG	MRG-001	Subjects will receive subcutaneous MRG-001 injections.
DRUG	Placebo	Subjects will receive subcutaneous placebo injections.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-31
• Completion: 2022-07-01
• First posted: 2020-11-30
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study