REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia

Study Overview
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Brief Summary
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To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.

Official Title
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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
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COVID19, ARDS

Intervention / Treatment
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* Biological: CK0802
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>Excipient | Drug: Placebo<br>* Expicient<br>|
| Experimental: Arm 2<br>CK0802: 1x10^8 cells | Biological: CK0802<br>* Cryopreserved, off the shelf, cord blood derived T regulatory cells<br>|
| Experimental: Arm 3<br>CK0802: 3x10^8 cells | Biological: CK0802<br>* Cryopreserved, off the shelf, cord blood derived T regulatory cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regimen related ≥ grade 3 toxicity within 48 hours of first infusion | Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT) | 48 hours | 
| 28-day treatment success, defined as S28 | Alive and not intubated 28 days after the date of first infusion | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Time to extubation | 28 days | 
| Oxygenation improvement | Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11 | 11 days | 
| Ventilator free days | Ventilator free days measured at day 28 | 28 days | 
| Organ failure free days | Organ failure free days measured at day 28 | 28 days | 
| ICU free days | ICU free days measured at day 28 | 28 days | 
| All-cause mortality | All-cause mortality at day 28 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, ARDS, CK0802, T regulatory cells, cord blood