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)
1 other identifier
interventional
45
1 country
5
Brief Summary
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Sep 2020
Typical duration for phase_1 covid19
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
September 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2021
CompletedMarch 10, 2022
March 1, 2022
1.1 years
July 10, 2020
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Time to extubation
28 days
Oxygenation improvement
11 days
Ventilator free days
28 days
Organ failure free days
28 days
ICU free days
28 days
- +1 more secondary outcomes
Study Arms (3)
Arm 1
PLACEBO COMPARATORExcipient
Arm 2
EXPERIMENTALCK0802: 1x10\^8 cells
Arm 3
EXPERIMENTALCK0802: 3x10\^8 cells
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cellenkos, Inc.lead
Study Sites (5)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Columbia University
New York, New York, 10027, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Baylor College of Medicine, St Luke's Hospital
Houston, Texas, 77005, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 13, 2020
Study Start
September 29, 2020
Primary Completion
October 22, 2021
Study Completion
October 22, 2021
Last Updated
March 10, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share