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

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)

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

Study Overview

• Status: Completed
• Conditions: ARDS; COVID19
• Intervention / Treatment: Drug: Placebo; Biological: CK0802

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • New York
    • New York, New York, United States, 10027
      • Columbia University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Texas
    • Houston, Texas, United States, 77005
      • Baylor College of Medicine, St Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. In the opinion of the investigator, unlikely to survive for >48 hours from screening.
2. 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.
3. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
4. Females who are pregnant.
5. 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.
6. Patients who have been intubated for more than 120 hours.
7. Known hypersensitivity to DMSO or to porcine or bovine protein.
8. Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
9. High dose steroids.
10. Receiving an investigational cellular therapy agent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cellenkos, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): October 22, 2021
• Study Completion (Actual): October 22, 2021

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ARDS; COVID19; CK0802; T regulatory cells; cord blood
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CK0802.501.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No