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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise (BR)

Primary Purpose

Covid19

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
COVI-MSC
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19, long haul, post-acute covid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
  • Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
  • Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Clinically improving pulmonary status over the month prior to screening
  • Undergone a previous stem cell infusion unrelated to this trial
  • Pregnant or breast feeding or planning for either during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection
  • Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
  • History of a splenectomy, lung transplant or lung lobectomy
  • Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    COVI-MSC

    Placebo

    Arm Description

    Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)

    Excipient

    Outcomes

    Primary Outcome Measures

    Change in 6-Minute Walk Distance (6MWD) at Day 60
    Change in 6MWD at Day 60

    Secondary Outcome Measures

    Change in 6MWD at Day 30
    Change in 6MWD at Day 30
    Relief of symptoms on Day 30 and Day 60
    Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit
    Change in Pulmonary Function
    Change in pulmonary function at Days 30 and 60, as measured by the single-breath test
    Change in oxygenation
    Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio
    Change in biomarker levels
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor

    Full Information

    First Posted
    July 28, 2021
    Last Updated
    April 10, 2023
    Sponsor
    Sorrento Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04992247
    Brief Title
    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
    Acronym
    BR
    Official Title
    A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sorrento Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.
    Detailed Description
    This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19
    Keywords
    covid19, long haul, post-acute covid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    COVI-MSC
    Arm Type
    Experimental
    Arm Description
    Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Excipient
    Intervention Type
    Biological
    Intervention Name(s)
    COVI-MSC
    Intervention Description
    2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
    Primary Outcome Measure Information:
    Title
    Change in 6-Minute Walk Distance (6MWD) at Day 60
    Description
    Change in 6MWD at Day 60
    Time Frame
    Baseline to Day 60
    Secondary Outcome Measure Information:
    Title
    Change in 6MWD at Day 30
    Description
    Change in 6MWD at Day 30
    Time Frame
    Baseline to Day 30
    Title
    Relief of symptoms on Day 30 and Day 60
    Description
    Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit
    Time Frame
    Baseline to Day 30 and Day 60
    Title
    Change in Pulmonary Function
    Description
    Change in pulmonary function at Days 30 and 60, as measured by the single-breath test
    Time Frame
    Baseline to Day 30 and Day 60
    Title
    Change in oxygenation
    Description
    Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio
    Time Frame
    Baseline to Day 30 and Day 60
    Title
    Change in biomarker levels
    Description
    Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
    Time Frame
    Baseline to Day 60

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test) Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status Willing to follow contraception guidelines Exclusion Criteria: Clinically improving pulmonary status over the month prior to screening Undergone a previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mike Royal, MD
    Phone
    (858)203-4100
    Ext
    4146
    Email
    mroyal@sorrentotherapeutics.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Royal, MD
    Organizational Affiliation
    Sorrento Therapeutics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

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