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

COVID19 Clinical Trial

— RESOLVE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468971
• Other study ID #: CK0802.501.1
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: March 2022
• Source: Cellenkos, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 22, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID-19
• COVID19

Intervention

Biological:
• CK0802
Cryopreserved, off the shelf, cord blood derived T regulatory cells

Drug:
• Placebo
Expicient

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Baylor College of Medicine, St Luke's Hospital	Houston	Texas
United States	Columbia University	New York	New York
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cellenkos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regimen related = grade 3 toxicity within 48 hours of first infusion	Regimen related = grade 3 toxicity within 48 hours of first infusion (DLT)	48 hours
Primary	28-day treatment success, defined as S28	Alive and not intubated 28 days after the date of first infusion	28 days
Secondary	Time to extubation	Time to extubation	28 days
Secondary	Oxygenation improvement	Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11	11 days
Secondary	Ventilator free days	Ventilator free days measured at day 28	28 days
Secondary	Organ failure free days	Organ failure free days measured at day 28	28 days
Secondary	ICU free days	ICU free days measured at day 28	28 days
Secondary	All-cause mortality	All-cause mortality at day 28	28 days