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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04468971
Recruitment Status : Active, not recruiting
First Posted : July 13, 2020
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Cellenkos, Inc.

Tracking Information
First Submitted Date  ICMJE July 10, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date June 22, 2021
Actual Study Start Date  ICMJE September 29, 2020
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • Regimen related ≥ grade 3 toxicity within 48 hours of first infusion [ Time Frame: 48 hours ]
    Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
  • 28-day treatment success, defined as S28 [ Time Frame: 28 days ]
    Alive and not intubated 28 days after the date of first infusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
  • Time to extubation [ Time Frame: 28 days ]
    Time to extubation
  • Oxygenation improvement [ Time Frame: 11 days ]
    Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
  • Ventilator free days [ Time Frame: 28 days ]
    Ventilator free days measured at day 28
  • Organ failure free days [ Time Frame: 28 days ]
    Organ failure free days measured at day 28
  • ICU free days [ Time Frame: 28 days ]
    ICU free days measured at day 28
  • All-cause mortality [ Time Frame: 28 days ]
    All-cause mortality at day 28
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia
Official Title  ICMJE 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)
Brief Summary To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID19
  • ARDS
Intervention  ICMJE
  • Biological: CK0802
    Cryopreserved, off the shelf, cord blood derived T regulatory cells
  • Drug: Placebo
    Expicient
Study Arms  ICMJE
  • Placebo Comparator: Arm 1
    Excipient
    Intervention: Drug: Placebo
  • Experimental: Arm 2
    CK0802: 1x10^8 cells
    Intervention: Biological: CK0802
  • Experimental: Arm 3
    CK0802: 3x10^8 cells
    Intervention: Biological: CK0802
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2020)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04468971
Other Study ID Numbers  ICMJE CK0802.501.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cellenkos, Inc.
Study Sponsor  ICMJE Cellenkos, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cellenkos, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP