Acute Respiratory Distress SyndromePhase 1NCT04737161
Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
A Phase 1 study testing T regulatory cells in people with Acute Respiratory Distress Syndrome and Covid19, run by Stanford University at 1 site in United States.
Trial summary
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Covid19
- What is being tested?
- T regulatory cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to Sep 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years to 75 years
- All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
- Provision of signed written informed consent from the patient or patients legally authorized representative
- Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
- Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
- COVID positive by PCR testing
Who cannot join
- Concurrent illness that shortens life expectancy to less than 6 months
- Inability to obtain adequate study follow-up
- Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.
Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Being tested
- T regulatory cells
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T regulatory cellsBiological
T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
| Study group | Role | What they receive |
|---|---|---|
| T regulatory cell infusion | Experimental | Infusion will be administered to the patient within 72 hours of collection from donor. Receives: Biological: T regulatory cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
Measured: within 6 hours of study infusion
The number of patients that experience treatment emergent AEs
Treatment related adverse events or serious adverse events
Measured: 6 to 24 hours after infusion treatment
The number of patients who receive the target dose for one or more intravenous infusions
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
Measured: up to 14 days (approximately 1.5 hours average per infusion)
Secondary outcomes (4)
The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
Measured: up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
The scale specifies a point value for each of the following parameters including: death (8 points), hospitalized on invasive mechanical ventilation and additional organ support including extracorporeal membrane oxygenation (ECMO) (7 points), hospitalized on invasive mechanical ventilation (6 points), hospitalized on non-invasive ventilation or high flow nasal cannula (HFNC) (5 points), hospitalized on supplemental oxygen (4 points), hospitalized not on supplemental oxygen (3 points), not hospitalized with limitation in activity (continued symptoms) (2 points) and not hospitalized without limitation in activity (no symptoms) (1 point) and no clinical or virological evidence of infection (0 points).
Measured: assessed at 28 days post-infusion
Change in Sequential Organ Failure Assessment (SOFA) Score over time
The SOFA score is designed to predict mortality based on the degree of dysfunction of six organ systems (neurologic, respiratory, cardiovascular, hepatic, coagulation and renal). Score range: 0-24 (summed from each of the 6 organ systems individually graded on a 0 to 4 scale); higher numbers represent a greater degree of organ dysfunction for the subscales and overall scale.
Measured: up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
Mortality following initial infusion
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 posted3 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Funding not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe L Hsu, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737161
- Sponsor's protocol ID
- 56248
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2021
- Last updated
- 19 Apr 2021
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT04737161
- Acronym / sponsor ID
- 56248
- Conditions
- Acute Respiratory Distress Syndrome, Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS.
Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T regulatory cell infusion | Experimental | Biological: T regulatory cellsInfusion will be administered to the patient within 72 hours of collection from donor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years to 75 years
- All patients at entry are required to be at high risk for the development of ARDS or receiving mechanical ventilatory support
- Provision of signed written informed consent from the patient or patients legally authorized representative
- Only patients who are committed to full life support (Do not resuscitate (DNR) allowed)
- Initiation of study drug within 120 hours of the diagnosis of acute lung injury (ALI)/ARDS
Key exclusion criteria (3 listed)
- Concurrent illness that shortens life expectancy to less than 6 months
- Inability to obtain adequate study follow-up
- Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
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 |
|---|---|---|
| T regulatory cellsT regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis. | Biological | T regulatory cell infusion |
Primary outcome
The number of participants that experience the occurrence of infusion associated adverse events (AEs)
Time frame: within 6 hours of study infusion
The number of patients that experience treatment emergent AEs
Time frame: 6 to 24 hours after infusion treatment
Treatment related adverse events or serious adverse events
The number of patients who receive the target dose for one or more intravenous infusions
Time frame: up to 14 days (approximately 1.5 hours average per infusion)
Patients will receive 1 or 2 infusions, with the possibility of a second infusion given 14 days after the initial infusion.
4 secondary outcomes
The ratio of average daily partial pressure of oxygen (PaO2) to average fraction of inspired oxygen (FiO2) (PaO2:FiO2) over time
Time frame: up to 14 days (assessed at baseline, and 3, 7, and 14 days post-infusion)
World Health Organization (WHO) COVID-19 ordinal scale score for clinical improvement
Time frame: assessed at 28 days post-infusion
Change in Sequential Organ Failure Assessment (SOFA) Score over time
Time frame: up to 14 days (assessed at baseline, and 1, 3, 5, 7, and 14 days post-infusion)
Mortality following initial infusion
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- 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.
Joe L Hsu, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T regulatory cells in people with Acute Respiratory Distress Syndrome and Covid19, run by Stanford University at 1 site 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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
The number of participants that experience the occurrence of infusion associated adverse events (AEs) (time frame: within 6 hours of study infusion). The study lists 3 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 19 Apr 2021.