Covid19
Conditions
Keywords
covid19, long haul, post-acute covid
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.
Interventions
BIOLOGICALCOVI-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
BIOLOGICALPlacebo
6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-Minute Walk Distance (6MWD) at Day 60 | Baseline to Day 60 | Change in 6MWD at Day 60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6MWD at Day 30 | Baseline to Day 30 | Change in 6MWD at Day 30 |
| Relief of symptoms on Day 30 and Day 60 | Baseline to 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 |
| Change in Pulmonary Function | Baseline to Day 30 and Day 60 | Change in pulmonary function at Days 30 and 60, as measured by the single-breath test |
| Change in oxygenation | Baseline to Day 30 and Day 60 | Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio |
| Change in biomarker levels | Baseline to Day 60 | Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor |
Outcome results
None listed