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

Sponsor

Cellenkos, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04468971

Collaborator

(none)

Enrollment

Locations

Arms

12.7

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID19 ARDS	Biological: CK0802 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Sep 29, 2020

Actual Primary Completion Date :

Oct 22, 2021

Actual Study Completion Date :

Oct 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 Excipient	Drug: Placebo Expicient
Experimental: Arm 2 CK0802: 1x10^8 cells	Biological: CK0802 Cryopreserved, off the shelf, cord blood derived T regulatory cells
Experimental: Arm 3 CK0802: 3x10^8 cells	Biological: CK0802 Cryopreserved, off the shelf, cord blood derived T regulatory cells

Arm

Intervention/Treatment

Placebo Comparator: Arm 1

Excipient

Drug: Placebo

Expicient

Experimental: Arm 2

CK0802: 1x10^8 cells

Biological: CK0802

Cryopreserved, off the shelf, cord blood derived T regulatory cells

Experimental: Arm 3

CK0802: 3x10^8 cells

Biological: CK0802

Cryopreserved, off the shelf, cord blood derived T regulatory cells

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Time to extubation [28 days]
Time to extubation
Oxygenation improvement [11 days]
Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
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
ICU free days [28 days]
ICU free days measured at day 28
All-cause mortality [28 days]
All-cause mortality at day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Baylor College of Medicine, St Luke's Hospital	Houston	Texas	United States	77005