NCT04992247
Withdrawn
Phase 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
ConditionsCovid19
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Sorrento Therapeutics, Inc.
- Primary Endpoint
- Change in 6-Minute Walk Distance (6MWD) at Day 60
- Status
- Withdrawn
- Last Updated
- 2 years ago
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.
Investigators
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)
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 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)
- Change in oxygenation(Baseline to Day 30 and Day 60)
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