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

Phase 1

Completed

• Conditions: ARDS; COVID19
• Interventions: Biological: CK0802; Drug: Placebo

• Registration Number: NCT04468971
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Start: 2020-09-29
• Primary Completion: 2021-10-22
• Study Completion: 2021-10-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	CK0802	CK0802: 3x10\^8 cells
Arm 1	Placebo	Excipient
Arm 2	CK0802	CK0802: 1x10\^8 cells

Primary Outcome Measures

Name	Time	Method
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion	48 hours	Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
28-day treatment success, defined as S28	28 days	Alive and not intubated 28 days after the date of first infusion

Secondary Outcome Measures

Name	Time	Method
Oxygenation improvement	11 days	Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
Ventilator free days	28 days	Ventilator free days measured at day 28
Organ failure free days	28 days	Organ failure free days measured at day 28
Time to extubation	28 days	Time to extubation
All-cause mortality	28 days	All-cause mortality at day 28
ICU free days	28 days	ICU free days measured at day 28

Trial Locations

Locations (5)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Columbia University; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Baylor College of Medicine, St Luke's Hospital; 🇺🇸 Houston, Texas, United States