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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04468971
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Cellenkos, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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
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 : September 29, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021


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




Primary Outcome Measures :
  1. 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)

  2. 28-day treatment success, defined as S28 [ Time Frame: 28 days ]
    Alive and not intubated 28 days after the date of first infusion


Secondary Outcome Measures :
  1. Time to extubation [ Time Frame: 28 days ]
    Time to extubation

  2. Oxygenation improvement [ Time Frame: 11 days ]
    Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11

  3. Ventilator free days [ Time Frame: 28 days ]
    Ventilator free days measured at day 28

  4. Organ failure free days [ Time Frame: 28 days ]
    Organ failure free days measured at day 28

  5. ICU free days [ Time Frame: 28 days ]
    ICU free days measured at day 28

  6. All-cause mortality [ Time Frame: 28 days ]
    All-cause mortality at day 28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468971


Contacts
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Contact: Tara Sadeghi 7138064787 tara.sadeghi@cellenkosinc.com

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Joby Mathew       jmathe27@jhmi.edu   
Sub-Investigator: Douglas Gladstone, MD         
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10027
Contact: Carlos Reyes-Vidal    212-305-4921    csr52@cumc.columbia.edu   
Sub-Investigator: Darryl Adams         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Colleen Rice    919-966-2531    colleen_rice@med.unc.edu   
Contact: Rice         
Principal Investigator: Jason Mock, MD,PhD         
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Pinchie Onyango    336-716-6591    ponyango@wakehealth.edu   
Principal Investigator: Kevin Harris         
United States, Texas
Baylor College of Medicine, St Luke's Hospital Not yet recruiting
Houston, Texas, United States, 77005
Contact: Sree Coimbatore    281-202-3975    coimbatore.sreevidya@bcm.edu   
Contact: Rafael Cardenas       Rafael.CardenasCastillo@bcm.edu   
Principal Investigator: Christopher Howard, MD         
Sponsors and Collaborators
Cellenkos, Inc.
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Responsible Party: Cellenkos, Inc.
ClinicalTrials.gov Identifier: NCT04468971    
Other Study ID Numbers: CK0802.501.1
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellenkos, Inc.:
COVID19
ARDS
CK0802
T regulatory cells
cord blood