Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646603
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
MedRegen LLC

Brief Summary:

The Study is Designed as A Combined Phase I Double-Blind Randomized Placebo controlled Study in Healthy Subjects /Phase IIa, Randomized, Double-blind, Placebo controlled, Multi-center Study in Subjects Infected with SARS CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Part A: To determine the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of MRG-001 in healthy subjects.

Part B: To determine the safety and efficacy profile of MRG-001 in patients with moderate-to-severe COVID-19. A total of 138 subjects will be enrolled and randomized in 1:1 ratio to receive MRG-001 or placebo. All subjects will be treated with the best available treatment. The follow-up period is up to 28 days.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: MRG-001 Drug: Placebo Phase 1 Phase 2

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. The combined phase I/IIa trial will involve 138 patients randomized into blinded placebo and MRG-001 arms, to determine the safety and efficacy profile of MRG-001 as the primary endpoint.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind Randomized Placebo-Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Combined Phase I Double-Blind Randomized Placebo Controlled Study in Healthy Subjects /Phase IIa, Randomized, Double-blind, Placebo Controlled, Multi-center Study in Subjects Infected With SARS CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 5, 2021

Arm Intervention/treatment
Experimental: MRG-001

Single SC dose of 0.005 mL/kg MRG-001 (n=4) will be administered every other day for the duration of 5 days totaling 3 injections.

Single SC dose of 0.01 mL/kg MRG-001 (n=4) will be administered every other day for the duration of 5 days totaling 3 injections.

Single SC dose of 0.02 mL/kg MRG-001 (n=4) will be administered every other day for the duration of 5 days totaling 3 injections.

Drug: MRG-001
Subjects will receive subcutaneous MRG-001 injections.

Placebo Comparator: Placebo

Single SC dose of 0.005 mL/kg Sterile Injectable Saline (n=2) will be administered every other day for the duration of 5 days totaling 3 injections.

Single SC dose of 0.01 mL/kg Sterile Injectable Saline (n=2) will be administered every other day for the duration of 5 days totaling 3 injections.

Single SC dose of 0.02 mL/kg Sterile Injectable Saline (n=2) will be administered every other day for the duration of 5 days totaling 3 injections.

Drug: Placebo
Subjects will receive subcutaneous placebo injections.




Primary Outcome Measures :
  1. Phase I [ Time Frame: 12 days ]
    Change from baseline in the proportion of subjects experiencing any treatment emergent adverse event (TEAE) associated with MRG-001 to Day 12.

  2. Phase IIa [ Time Frame: 28 days ]
    Time to clinical improvement from randomization to Day 28 by at least 2 points on the 8-point ordinal scale of WHO clinical improvement scale (1 = discharged; 8 = death).


Secondary Outcome Measures :
  1. Change in percentages from baseline in circulating white blood cell subpopulations [ Time Frame: 12 days ]
  2. Change in Plerixafor concentration (ng/ml) from baseline in blood [ Time Frame: 12 days ]
  3. Change in Tacrolimus concentration (ng/ml) from baseline in blood [ Time Frame: 12 days ]
  4. Change from baseline in ALT, AST [ Time Frame: 12 days ]
  5. Change in percentages from baseline in circulating stem cells and immune cells [ Time Frame: 12 days ]
  6. Change from baseline in platelets [ Time Frame: 12 days ]
  7. Change from baseline in total Bilirubin [ Time Frame: 12 days ]
  8. Change from baseline in LDH [ Time Frame: 12 days ]
  9. Change from baseline in blood urea nitrogen (BUN) [ Time Frame: 12 days ]
  10. Change from baseline in glomerular filtration rate (GFR) [ Time Frame: 12 days ]
  11. Change from baseline in hemoglobin [ Time Frame: 12 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
  2. Males and females between 18 to 45 years of age, inclusive, at the time of signing the ICF.
  3. Subjects who test negative for SARS-CoV-2 by real time transcription polymerase chain reaction in the respiratory tract (nasopharyngeal [NP] swab) within the previous 96 hours.
  4. Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (< 500 ng/mL) at the Screening Visit and admission.
  5. Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
  6. The following applies to female subjects:

    •Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide or intrauterine device) from the Screening Visit until the End-of-study Visit.

  7. Body mass index (BMI) between 18.8 and 29.9 kg/m2, inclusive, at the Screening Visit.
  8. A fasting blood glucose level ≤125 mg/dL (6.9 mmol/L), at the Screening Visit.

Exclusion Criteria:

  1. Participation in any other clinical trial of an experimental treatment for COVID-19 (remdesivir and convalescent plasma use is permitted).
  2. Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
  3. Concurrent treatment with other agents with actual or possible direct acting immunomodulatory activity against ARDS in COVID-19 is prohibited <72 hours prior to study drug dosing [IL-6 inhibitors such as sarilumab and tocilizumab; IL-1β blocker; and the JAK1/JAK2 inhibitor ruxolitinib, barcitinib and tofacitinib; complement inhibitor ravulizumab-cwvz; Bruton's tyrosine kinase inhibitor acalabrutinib, and macrophage migration inhibitor ibudilast].
  4. History of splenomegaly (spleen weighing >750 g).
  5. History of cancer or thrombocytopenia (platelet count <100,000/µL) or thrombocythemia (platelet count >500,000/µL).
  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. Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of study drug.
  9. Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
  10. Received a vaccination (including influenza) administered 30 days or less prior to first treatment/randomization or has any planned vaccinations during the treatment period.
  11. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula.
  12. Has the following liver function levels:

    Serum ALP or BIL >1.5 ULN or ALT or AST >ULN (Part A); Serum ALP or BIL >3.0 ULN or ALT or AST >5.0x ULN (Part B); at either screening or admission. Only 1 repeat assessment is allowed on each occasion.

  13. History of alcohol and/or illicit drug abuse within 2 years of entry.
  14. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody.
  15. Has a positive blood test for ethanol at the Screening Visit or admission.
  16. Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at the Screening Visit or admission.
  17. Has donated blood (>500 mL) or blood products within 2 months (56 days) prior to admission.
  18. Has used an investigational drug within 30 days prior to Screening.
  19. 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.
  20. Unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
  21. 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.
  22. Previously been enrolled in this clinical study.
  23. 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).
  24. Laboratory-confirmation of SARS-CoV-2 by real time polymerase chain reaction in the respiratory tract (NP swab, tracheal aspirate, BAL) ≤96 hours prior to randomization.
  25. Is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to screening until discharge from the clinical site.
  26. Is unable to abstain from smoking (or other nicotine use) from screening until discharge from the clinical site.
  27. Has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study such as:

    1. Skin condition or disease (e.g., Stevens-Johnson syndrome).
    2. Hypertension defined as >140 mmHg systolic blood pressure and >95 mmHg diastolic blood pressure.
    3. High blood potassium (hyperkalemia) defined baseline serum potassium >5.0 to 5.5 mEq/L (milliequivalent).
    4. Torsades de Pointes or currently taking medication that prolongs QT interval.
    5. Hematologic disorder (e.g. anemia or leukemia).
    6. Type I or Type 2 diabetes mellitus defined as a fasting blood glucose level >126 mg/dL (7.0 mmol/L).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646603


Contacts
Layout table for location contacts
Contact: James F Burdick, MD +14437598563 info@medregenco.com
Contact: Ali R Ahmadi, PhD +14437598563 info@medregenco.com

Locations
Layout table for location information
United States, Texas
ICON Early Phase Services Recruiting
San Antonio, Texas, United States, 78209
Contact: Denese Haak         
Sponsors and Collaborators
MedRegen LLC
ICON plc
Investigators
Layout table for investigator information
Principal Investigator: George Atiee, MD ICON plc
Layout table for additonal information
Responsible Party: MedRegen LLC
ClinicalTrials.gov Identifier: NCT04646603    
Other Study ID Numbers: MRG2020
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No