NCT04468971CompletedPhase 1
Phase 1 Double-Blinded, Randomized, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) In The Treatment Of COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cellenkos, Inc.
- Enrollment
- 45
- Locations
- 5
- Primary Endpoint
- Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
Study Overview
Brief Summary
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
Arm 1
Placebo Comparator
Excipient
Intervention: Placebo (Drug)
Arm 2
Experimental
CK0802: 1x10^8 cells
Intervention: CK0802 (Biological)
Arm 3
Experimental
CK0802: 3x10^8 cells
Intervention: CK0802 (Biological)
Outcomes
Primary Outcomes
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
Time Frame: 48 hours
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
28-day treatment success, defined as S28
Time Frame: 28 days
Alive and not intubated 28 days after the date of first infusion
Secondary Outcomes
- Oxygenation improvement(11 days)
- Ventilator free days(28 days)
- Organ failure free days(28 days)
- Time to extubation(28 days)
- All-cause mortality(28 days)
- ICU free days(28 days)
Investigators
Study Sites (5)
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