COVID19Phase 1RESOLVENCT04468971
REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia
A Phase 1 study testing CK0802 in people with COVID19 and ARDS, run by Cellenkos, Inc. at 5 sites in United States.
Trial summary
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CK0802
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Sep 2020to 22 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of North Carolina
Chapel Hill, North Carolina, 27514
Baylor College of Medicine, St Luke's Hospital
Houston, Texas, 77005
Columbia University
New York, New York, 10027
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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)
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
- Being tested
- CK0802, Placebo
- Keywords
- COVID19, ARDS, CK0802, T regulatory cells, cord blood
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK0802Biological
Cryopreserved, off the shelf, cord blood derived T regulatory cells
PlaceboDrug
Expicient
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Excipient Receives: Drug: Placebo |
| Arm 2 | Experimental | CK0802: 1x10^8 cells Receives: Biological: CK0802 |
| Arm 3 | Experimental | CK0802: 3x10^8 cells Receives: Biological: CK0802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (DLT)
Measured: 48 hours
28-day treatment success, defined as S28
Alive and not intubated 28 days after the date of first infusion
Measured: 28 days
Secondary outcomes (6)
Time to extubation
Time to extubation
Measured: 28 days
Oxygenation improvement
Oxygenation requirement (PaO2/FiO2) change between day 0 and day +11
Measured: 11 days
Ventilator free days
Ventilator free days measured at day 28
Measured: 28 days
Organ failure free days
Organ failure free days measured at day 28
Measured: 28 days
ICU free days
ICU free days measured at day 28
Measured: 28 days
All-cause mortality
All-cause mortality at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start29 Sep 2020
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellenkos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468971
- Sponsor's protocol ID
- CK0802.501.1
- Acronym
- RESOLVE
- Status last verified
- Mar 2022
- First submitted
- 10 Jul 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04468971
- Acronym / sponsor ID
- RESOLVE / CK0802.501.1
- Keywords
- COVID19, ARDS, CK0802, T regulatory cells, cord blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cellenkos, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of CK0802 in treatment of patients with COVID-19 induced moderate-to-severe PNA-ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multi-center, prospective, double-blinded, placebo controlled Phase 1 randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: PlaceboExcipient |
| Arm 2 | Experimental | Biological: CK0802CK0802: 1x10^8 cells |
| Arm 3 | Experimental | Biological: CK0802CK0802: 3x10^8 cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK0802Cryopreserved, off the shelf, cord blood derived T regulatory cells | Biological | Arm 2, Arm 3 |
| PlaceboExpicient | Drug | Arm 1 |
Primary outcome
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
6 secondary outcomes
Time to extubation
Time frame: 28 days
Oxygenation improvement
Time frame: 11 days
Ventilator free days
Time frame: 28 days
Organ failure free days
Time frame: 28 days
ICU free days
Time frame: 28 days
All-cause mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CK0802 in people with COVID19 and ARDS, run by Cellenkos, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regimen related ≥ grade 3 toxicity within 48 hours of first infusion (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.