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.
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.
Biological: COVI-MSC
2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group.
Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4
Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4
Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2
Group D: 2 MSC vials infused on D0, D2 and D4
Biological: Placebo
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
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)
Mike Royal, MD
(858)203-4100 - 4146
mroyal@sorrentotherapeutics.com
Mike Royal, MD, Study Director
Sorrento Therapeutics, Inc.