Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
COVI-MSC
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring covid-19, long haul, post-acute covid
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
- 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
Experimental
Arm Label
COVI-MSC 1 vial
COVI-MSC 2 vials
Arm Description
Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
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
Change in Pulmonary Function Tests (PFTs)
Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)
Change in oxygenation
Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio
Change in biomarker levels
Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
Full Information
NCT ID
NCT04909892
First Posted
May 29, 2021
Last Updated
September 14, 2021
Sponsor
Sorrento Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04909892
Brief Title
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Official Title
A Phase 2a 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
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Replaced by a different protocol.
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (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 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.
Detailed Description
This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with 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
covid-19, long haul, post-acute covid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVI-MSC 1 vial
Arm Type
Experimental
Arm Description
Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
Arm Title
COVI-MSC 2 vials
Arm Type
Experimental
Arm Description
Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
Intervention Type
Biological
Intervention Name(s)
COVI-MSC
Intervention Description
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
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
Change in Pulmonary Function Tests (PFTs)
Description
Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)
Time Frame
Baseline to Day 30 and Day 60
Title
Change in oxygenation
Description
Change in oxygenation at Days 30 and 60, as measured using 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 through Day 30
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
History of a splenectomy, lung transplant or lung lobectomy
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
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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