REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia (RESOLVE)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04468971 |
Recruitment Status :
Completed
First Posted : July 13, 2020
Last Update Posted : March 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID19 ARDS | Biological: CK0802 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | October 22, 2021 |
Actual Study Completion Date : | October 22, 2021 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Arm 1
Excipient
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Drug: Placebo
Expicient |
Experimental: Arm 2
CK0802: 1x10^8 cells
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Biological: CK0802
Cryopreserved, off the shelf, cord blood derived T regulatory cells |
Experimental: Arm 3
CK0802: 3x10^8 cells
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Biological: CK0802
Cryopreserved, off the shelf, cord blood derived T regulatory cells |
- 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)
- 28-day treatment success, defined as S28 [ Time Frame: 28 days ]Alive and not intubated 28 days after the date of first infusion
- Time to extubation [ Time Frame: 28 days ]Time to extubation
- Oxygenation improvement [ Time Frame: 11 days ]Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
- Ventilator free days [ Time Frame: 28 days ]Ventilator free days measured at day 28
- Organ failure free days [ Time Frame: 28 days ]Organ failure free days measured at day 28
- ICU free days [ Time Frame: 28 days ]ICU free days measured at day 28
- All-cause mortality [ Time Frame: 28 days ]All-cause mortality at day 28

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- In the opinion of the investigator, unlikely to survive for >48 hours from screening.
- 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.
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
- Females who are pregnant.
- 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.
- Patients who have been intubated for more than 120 hours.
- Known hypersensitivity to DMSO or to porcine or bovine protein.
- Any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of CK0802 treatment.
- High dose steroids.
- Receiving an investigational cellular therapy agent.

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
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10027 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Texas | |
Baylor College of Medicine, St Luke's Hospital | |
Houston, Texas, United States, 77005 |
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: | March 10, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID19 ARDS CK0802 T regulatory cells cord blood |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |