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

Launched by MEDREGEN LLC · Nov 25, 2020

Keywords

ClinConnect Summary

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 th...

Gender

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Eligibility criteria

• • Inclusion Criteria
• • 1. 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.
• • 2. Males and females over 18 years of age, inclusive, at the time of signing the ICF.
• • 3. 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.
• • 4. 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.
• • 5. Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection.
• • 6. 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.
• • 7. 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.
• • Exclusion Criteria
• • 1. Participation in any other clinical trial of an experimental treatment for COVID-19 (remdesivir use is permitted).
• • 2. Significant pre-existing organ dysfunction prior to randomization
• • 1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record
• • 2. 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.
• • 3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR \<30 mL/min
• • 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C
• • 5. Hematologic: Baseline platelet count \<50,000/mm3
• • 2. 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.
• • 3. History of splenectomy or splenomegaly (spleen weighing \>750 g).
• • 4. Body mass index of \>45 kg/m2 at screening
• • 5. Underlying malignancy, or other condition, with estimated life expectancy of less than two months
• • 6. Known family history of long QT syndrome (Torsades de Pointes) or currently taking medication that prolongs QT interval.
• • 7. Currently taking immunomodulating biologics (e.g., interferons, interleukin).
• • 8. Extracorporeal membrane oxygenation (ECMO).
• • 9. Use of two or more vasopressors.
• • 10. Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of IP.
• • 11. Received a live-attenuated vaccine within 30 days prior to enrollment.
• • 12. 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.
• • 13. Ongoing immunosuppression: solid organ transplant recipients.
• • 14. Has used an investigational drug within 30 days prior to Screening.
• • 15. 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.
• • 16. Current treatment with an anti-viral medication for COVID-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir.
• • 17. Unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
• • 18. 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.
• • 19. Previously been enrolled in this clinical study.
• • 20. Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent).
• • 21. Any condition that in the opinion of the treating physician will increase the risk for the participant.