Clinical trial NCT04468971: REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID19
ARDS
Keywords: COVID19
ARDS
CK0802
T regulatory cells
cord blood
Lead sponsor: Cellenkos, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
Primary purpose: TREATMENT

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


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:

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.

Primary outcomes:
measure: Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
timeFrame: 48 hours
measure: 28-day treatment success, defined as S28
timeFrame: 28 days
Secondary outcomes:
measure: Time to extubation
timeFrame: 28 days
measure: Oxygenation improvement
timeFrame: 11 days
measure: Ventilator free days
timeFrame: 28 days
measure: Organ failure free days
timeFrame: 28 days
measure: ICU free days
timeFrame: 28 days
measure: All-cause mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine, St Luke's Hospital
state: Texas
Study officials:
References: