To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Biological: CK0802
Cryopreserved, off the shelf, cord blood derived T regulatory cells
Drug: Placebo
Expicient
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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Baylor College of Medicine, St Luke's Hospital
Houston, Texas, United States