- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04909892
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
September 14, 2021 updated by: Sorrento Therapeutics, Inc.
A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
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.
Study Overview
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.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COVI-MSC 1 vial
Subjects will receive intravenous infusions of COVI-MSC (one vial, ~18.5 million cells) on Day 0, Day 2, and Day 4.
|
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
|
Experimental: COVI-MSC 2 vials
Subjects will receive intravenous infusions of COVI-MSC (two vials, ~37 million cells) on Day 0, Day 2, and Day 4.
|
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 6-Minute Walk Distance (6MWD) at Day 60
Time Frame: Baseline to Day 60
|
Change in 6MWD at Day 60
|
Baseline to Day 60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 6MWD at Day 30
Time Frame: Baseline to Day 30
|
Change in 6MWD at Day 30
|
Baseline to Day 30
|
Change in Pulmonary Function Tests (PFTs)
Time Frame: Baseline to Day 30 and Day 60
|
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)
|
Baseline to Day 30 and Day 60
|
Change in oxygenation
Time Frame: Baseline to Day 30 and Day 60
|
Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio
|
Baseline to Day 30 and Day 60
|
Change in biomarker levels
Time Frame: Baseline through Day 30
|
Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor
|
Baseline through Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
May 29, 2021
First Submitted That Met QC Criteria
May 29, 2021
First Posted (Actual)
June 2, 2021
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 14, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSC-PLH-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on COVI-MSC
-
Sorrento Therapeutics, Inc.Withdrawn
-
Sorrento Therapeutics, Inc.Withdrawn
-
Sorrento Therapeutics, Inc.Recruiting
-
Sorrento Therapeutics, Inc.WithdrawnAcute Respiratory Distress Syndrome | Ards
-
Sorrento Therapeutics, Inc.Terminated
-
Codagenix, IncCompletedCOVID-19 | SARS-CoV-2United Kingdom
-
Codagenix, IncCompletedCOVID-19United Kingdom
-
Hadassah Medical OrganizationCompleted
-
Fu-Sheng WangUnknownHuman Immunodeficiency Virus | Disorder of Immune ReconstitutionChina
-
Sorrento Therapeutics, Inc.Withdrawn