COVID-19Phase 2NCT04646603
MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients
A Phase 2 study testing MRG-001 in people with COVID-19 and ARDS, Human, run by MedRegen LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, ARDS, Human, Stem Cells
- What is being tested?
- MRG-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21205
Sherry Leung
About this study
Official title: 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
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
Read the 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.
Part A has been completed in May 01, 2021.
Part B has been initiated in January 2022.
- Conditions
- COVID-19, ARDS, Human, Stem Cells, Regeneration
- Being tested
- MRG-001, Placebo
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-001Drug
Subjects will receive subcutaneous MRG-001 injections.
PlaceboDrug
Subjects will receive subcutaneous placebo injections.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To evaluate the safety (SAE's) of MRG-001 in Severe and Critical SARS-CoV-2 patients.
Measured: 60 days
Secondary outcomes (7)
Change in percentages from baseline in circulating white blood cell subpopulations
Measured: 15 days
Change in Plerixafor concentration (ng/ml) from baseline in blood
Measured: 15 days
Change in Tacrolimus concentration (ng/ml) from baseline in blood
Measured: 15 days
Change from baseline in ALT, AST, INR, Albumin, Bilirubin, LDH, BUN, eGFR
Measured: 15 days
Change in percentages from baseline in circulating stem cells and immune cells
Measured: 15 days
All-cause mortality assessed at 14, 28 and 60 days following randomization.
Measured: 60 days
Time to clinical improvement from randomization by at least 2 points on the 8-point ordinal scale of WHO clinical improvement scale assessed up to 14 and 60 days (1=Asymptomatic, no limitations of activities; 8=death).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Dec 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind Randomized Placebo-Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedRegen LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Russell N Wesson, M.B.Ch.B, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646603
- Sponsor's protocol ID
- MRG2020
- Status last verified
- Jan 2022
- First submitted
- 24 Nov 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37633275
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04646603
- Acronym / sponsor ID
- MRG2020
- Conditions
- COVID-19, ARDS, Human, Stem Cells, Regeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MedRegen LLCIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc, Johns Hopkins University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Part A has been completed in May 01, 2021.
Part B has been initiated in January 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blind Randomized Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MRG-001 | Experimental | Drug: MRG-001Multiple 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. |
| Placebo | Placebo comparator | Drug: PlaceboSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG-001Subjects will receive subcutaneous MRG-001 injections. | Drug | MRG-001 |
| PlaceboSubjects will receive subcutaneous placebo injections. | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 60 days
To evaluate the safety (SAE's) of MRG-001 in Severe and Critical SARS-CoV-2 patients.
7 secondary outcomes
Change in percentages from baseline in circulating white blood cell subpopulations
Time frame: 15 days
Change in Plerixafor concentration (ng/ml) from baseline in blood
Time frame: 15 days
Change in Tacrolimus concentration (ng/ml) from baseline in blood
Time frame: 15 days
Change from baseline in ALT, AST, INR, Albumin, Bilirubin, LDH, BUN, eGFR
Time frame: 15 days
Change in percentages from baseline in circulating stem cells and immune cells
Time frame: 15 days
All-cause mortality assessed at 14, 28 and 60 days following randomization.
Time frame: 60 days
Time to clinical improvement from randomization by at least 2 points on the 8-point ordinal scale of WHO clinical improvement scale assessed up to 14 and 60 days (1=Asymptomatic, no limitations of activities; 8=death).
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 37633275Ahmadi 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell N Wesson, M.B.Ch.B principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG-001 in people with COVID-19 and ARDS, Human, run by MedRegen LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali R Ahmadi, MD PhD (+14437598563, info@medregenco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.