Covid19
Conditions
Keywords
covid-19, long haul, post-acute covid
Brief summary
This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 long haulers with pulmonary compromise.
Detailed description
This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 long haulers with pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.
Interventions
BIOLOGICALCOVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 * 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 |
| Change in Pulmonary Function Tests (PFTs) | Baseline to Day 30 and Day 60 | Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO) |
| Change in oxygenation | Baseline to Day 30 and Day 60 | Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio |
| Change in biomarker levels | Baseline through Day 30 | Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor |
Outcome results
None listed