NCT04646603

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

November 24, 2020

Last Update Submit

January 30, 2022

Conditions

COVID-19ARDS, HumanStem CellsRegeneration

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    To evaluate the safety (SAE's) of MRG-001 in Severe and Critical SARS-CoV-2 patients.

    60 days

Secondary Outcomes (7)

  • Change in percentages from baseline in circulating white blood cell subpopulations

    15 days

  • Change in Plerixafor concentration (ng/ml) from baseline in blood

    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

  • +2 more secondary outcomes

Study Arms (2)

MRG-001

EXPERIMENTAL

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.

Drug: MRG-001

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

MRG-001DRUG

Subjects will receive subcutaneous MRG-001 injections.

MRG-001
PlaceboDRUG

Subjects will receive subcutaneous placebo injections.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Males and females over 18 years of age, inclusive, at the time of signing the ICF.
  • 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.
  • 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.
  • Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection.
  • 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.
  • 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.

You may not qualify if:

  • \. Participation in any other clinical trial of an experimental treatment for COVID-19 (remdesivir use is permitted).
  • \. Significant pre-existing organ dysfunction prior to randomization
  • Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record
  • 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.
  • Renal: End-stage renal disease requiring renal replacement therapy or eGFR \<30 mL/min
  • Liver: Severe chronic liver disease defined as Child-Pugh Class C
  • Hematologic: Baseline platelet count \<50,000/mm3
  • \. 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.
  • \. History of splenectomy or splenomegaly (spleen weighing \>750 g).
  • \. Body mass index of \>45 kg/m2 at screening
  • \. Underlying malignancy, or other condition, with estimated life expectancy of less than two months
  • \. Known family history of long QT syndrome (Torsades de Pointes) or currently taking medication that prolongs QT interval.
  • \. Currently taking immunomodulating biologics (e.g., interferons, interleukin).
  • \. Extracorporeal membrane oxygenation (ECMO).
  • \. Use of two or more vasopressors.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (1)

  • Ahmadi AR, Atiee G, Chapman B, Reynolds L, Sun J, Cameron AM, Wesson RN, Burdick JF, Sun Z. A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects. Cell Rep Med. 2023 Sep 19;4(9):101169. doi: 10.1016/j.xcrm.2023.101169. Epub 2023 Aug 25.

    PMID: 37633275DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Russell N Wesson, M.B.Ch.B

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali R Ahmadi, MD PhD

CONTACT

+14437598563info@medregenco.com

James Burdick, MD

CONTACT

+14437598563info@medregenco.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-Blind Randomized Placebo-Controlled Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

November 30, 2020

Study Start

December 1, 2021

Primary Completion

March 31, 2022

Study Completion

July 1, 2022

Last Updated

February 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Participants will be given a unique unidentifiable study ID number and all data will be recorded according to unidentifiable number to protect patients personal health information.

Locations

US(1)