Status:
COMPLETED
REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia
Lead Sponsor:
Cellenkos, Inc.
Conditions:
COVID19
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Eligibility Criteria
Inclusion
- 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
- In the opinion of the investigator, unlikely to survive for \>48 hours from screening.
- 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.
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
- Females who are pregnant.
- 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.
- Patients who have been intubated for more than 120 hours.
- Known hypersensitivity to DMSO or to porcine or bovine protein.
- Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
- High dose steroids.
- Receiving an investigational cellular therapy agent.
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04468971
Start Date
September 29 2020
End Date
October 22 2021
Last Update
March 10 2022
Active Locations (5)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Columbia University
New York, New York, United States, 10027
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
4
Wake Forest University
Winston-Salem, North Carolina, United States, 27157