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

NCT04646603 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-15

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

MRG-001

Subjects will receive subcutaneous MRG-001 injections.

DRUG

Placebo

Subjects will receive subcutaneous placebo injections.

Sponsors & Collaborators

Principal Investigators

  • Russell N Wesson, M.B.Ch.B · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-03-31
Completion
2022-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04646603 on ClinicalTrials.gov