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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: COVID-19, ARDS, Human, Stem Cells, Regeneration

In brief

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

Key facts

Study ID

NCT04646603

Run by

MedRegen LLC

People needed

40

Starts

2021-12-01

Expected to finish

2022-07-01

Last updated by the study team

2022-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of IP.
• Received a live-attenuated vaccine within 30 days prior to enrollment.
• Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, human immunodeficiency virus (HIV) antibody or Active tuberculosis or a history of inadequately treated tuberculosis.
• Ongoing immunosuppression: solid organ transplant recipients.
• Has used an investigational drug within 30 days prior to Screening.
• History of hypersensitivity to MRG-001 (plerixafor [AMD3100, 24 mg/mL]) and tacrolimus [FK506, 0.5 mg/mL]) or any of the excipients or to medicinal products with similar chemical structures.
• Current treatment with an anti-viral medication for COVID-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir.
• Unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
• Unlikely to comply with the protocol requirements, instructions and study related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
• Previously been enrolled in this clinical study.

Where it is running

• Johns Hopkins Medicine — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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