ARDS, COVID19
Conditions
Keywords
COVID19, ARDS, CK0802, T regulatory cells, cord blood
Brief summary
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Interventions
BIOLOGICALCK0802
Cryopreserved, off the shelf, cord blood derived T regulatory cells
DRUGPlacebo
Expicient
Sponsors
Cellenkos, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented to have an RT-PCR-based diagnosis of SARS-CoV-2 infection by RT-PCR * Moderate-to-severe ARDS as defined by the Berlin Criteria: ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of 200 mm Hg or less assessed with a positive end-expiratory pressure (PEEP) of \>5 cm H2O. * Intubated for less than 120 hours * Age ≥18 years * Ability to provide informed consent or duly appointment health care proxy with the authority to provide informed consent.
Exclusion criteria
1. In the opinion of the investigator, unlikely to survive for \>48 hours from screening. 2. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study. 3. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV). 4. Females who are pregnant. 5. Patients with active bacteremia at start of therapy enrollment or concurrently active moderate to severe other infectious which in the opinion of the investigator may possibly affect the safety of CK0802 treatment. 6. Patients who have been intubated for more than 120 hours. 7. Known hypersensitivity to DMSO or to porcine or bovine protein. 8. Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment. 9. High dose steroids. 10. Receiving an investigational cellular therapy agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regimen related ≥ grade 3 toxicity within 48 hours of first infusion | 48 hours | Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT) |
| 28-day treatment success, defined as S28 | 28 days | Alive and not intubated 28 days after the date of first infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days | 28 days | Ventilator free days measured at day 28 |
| Organ failure free days | 28 days | Organ failure free days measured at day 28 |
| Time to extubation | 28 days | Time to extubation |
| All-cause mortality | 28 days | All-cause mortality at day 28 |
| ICU free days | 28 days | ICU free days measured at day 28 |
| Oxygenation improvement | 11 days | Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11 |
Countries
United States
Outcome results
None listed