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

Primary Purpose

COVID19, ARDS

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CK0802

Placebo

About this trial

This is an interventional treatment trial for COVID19 focused on measuring COVID19, ARDS, CK0802, T regulatory cells, cord blood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Johns Hopkins Hospital
Columbia University
University of North Carolina
Wake Forest University
Baylor College of Medicine, St Luke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Excipient

CK0802: 1x10^8 cells

CK0802: 3x10^8 cells

Outcomes

Primary Outcome Measures

Regimen related ≥ grade 3 toxicity within 48 hours of first infusion

Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)

28-day treatment success, defined as S28

Alive and not intubated 28 days after the date of first infusion

Secondary Outcome Measures

Time to extubation

Oxygenation improvement

Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11

Ventilator free days

Ventilator free days measured at day 28

Organ failure free days

Organ failure free days measured at day 28

ICU free days

ICU free days measured at day 28

All-cause mortality

All-cause mortality at day 28

Full Information

NCT ID

NCT04468971

First Posted

July 10, 2020

Last Updated

March 8, 2022

Sponsor

Cellenkos, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04468971

Brief Title

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

Acronym

RESOLVE

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

September 29, 2020 (Actual)

Primary Completion Date

October 22, 2021 (Actual)

Study Completion Date

October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cellenkos, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID19, ARDS

Keywords

COVID19, ARDS, CK0802, T regulatory cells, cord blood

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Placebo Comparator

Arm Description

Excipient

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

CK0802: 1x10^8 cells

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

CK0802: 3x10^8 cells

Intervention Type

Biological

Intervention Name(s)

CK0802

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Expicient

Primary Outcome Measure Information:

Title

Regimen related ≥ grade 3 toxicity within 48 hours of first infusion

Description

Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)

Time Frame

48 hours

Title

28-day treatment success, defined as S28

Description

Alive and not intubated 28 days after the date of first infusion

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Time to extubation

Description

Time to extubation

Time Frame

28 days

Title

Oxygenation improvement

Description

Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11

Time Frame

11 days

Title

Ventilator free days

Description

Ventilator free days measured at day 28

Time Frame

28 days

Title

Organ failure free days

Description

Organ failure free days measured at day 28

Time Frame

28 days

Title

ICU free days

Description

ICU free days measured at day 28

Time Frame

28 days

Title

All-cause mortality

Description

All-cause mortality at day 28

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10027

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Baylor College of Medicine, St Luke's Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77005

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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