Covid19 Clinical Trial
— BROfficial 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
Verified date | April 2024 |
Source | Sorrento Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sorrento Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 6-Minute Walk Distance (6MWD) at Day 60 | Change in 6MWD at Day 60 | Baseline to Day 60 | |
Secondary | Change in 6MWD at Day 30 | Change in 6MWD at Day 30 | Baseline to Day 30 | |
Secondary | 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 | Baseline to Day 30 and Day 60 | |
Secondary | Change in Pulmonary Function | Change in pulmonary function at Days 30 and 60, as measured by the single-breath test | Baseline to Day 30 and Day 60 | |
Secondary | Change in oxygenation | Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio | Baseline to Day 30 and Day 60 | |
Secondary | Change in biomarker levels | Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor | Baseline to Day 60 |
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