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

Cellenkos

Status and phase: Completed; Phase 1

Conditions: COVID19; ARDS

Treatments: Drug: Placebo; Biological: CK0802

Study type: Interventional

Funder types: Industry

Identifiers

NCT04468971

CK0802.501.1

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Excipient

Treatment:

Drug: Placebo

Arm 2

Experimental group

Description:

CK0802: 1x10\^8 cells

Treatment:

Biological: CK0802

Arm 3

Experimental group

Description:

CK0802: 3x10\^8 cells

Treatment:

Biological: CK0802