NCT04992247WithdrawnPhase 2
A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Sorrento Therapeutics, Inc.
- Primary Endpoint
- Change in 6-Minute Walk Distance (6MWD) at Day 60
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Placebo
Placebo Comparator
Excipient
Intervention: Placebo (Biological)
COVI-MSC
Experimental
Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs)
Intervention: COVI-MSC (Biological)
Outcomes
Primary Outcomes
Change in 6-Minute Walk Distance (6MWD) at Day 60
Time Frame: Baseline to Day 60
Change in 6MWD at Day 60
Secondary Outcomes
- Change in oxygenation(Baseline to Day 30 and Day 60)
- Change in biomarker levels(Baseline to Day 60)
- Change in Pulmonary Function(Baseline to Day 30 and Day 60)
- Change in 6MWD at Day 30(Baseline to Day 30)
- Relief of symptoms on Day 30 and Day 60(Baseline to Day 30 and Day 60)
Investigators
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