Moderate COVID-19-infectionPhase 1ACT-COVID-19NCT04762186
Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19
A Phase 1 study testing human SARS-CoV 2 specific T lymphocytes in people with Moderate COVID-19-infection, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Moderate COVID-19-infection
- What is being tested?
- human SARS-CoV 2 specific T lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2021to 3 Aug 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Written informed consent from the trial subject has been obtained
- Willing to follow contraception guidelines
- Tested positive for SARS-CoV-2 by PCR <72 hours after swab
- A maximum of 14 days between onset of symptoms and enrollment
- WHO score 5 OR
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- WHO score 4 with at least one additional risk factor for disease progression
- Acceptable risk factors are:
- Radiographically proven lung infiltrates
- Immunosuppression either by malignant disease or it's treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
- Immunosuppressive drugs or steroids at a prednisolone equivalent of <1 mg/kg BW)
- Receipt of an autologous transplant within the last 5 years
- Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression
Who cannot join
- Participation in any other clinical trial of an experimental agent treatment
- Active GvHD or history of GvHD
- History of CAR-T-Cell Therapy
- COVID-19 WHO ordinal scale ≥6
- Anticipated life-expectancy <72 hours
- Expected duration of hospital stay <72 hours
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- Sepsis-induced leukopenia or thrombocytopenia (leukocytes <1,000/µl or platelets <50,000/µl). If the cytopenias result from underlying hematologic disease or its treatment this will not be regarded as exclusion criterion
- CT pneumonia score ≥13 [50]
- Any Steroids ≥1 mg/kg Prednisolon-equivalent/kg BW, besides 6 mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
- Pregnant or breast feeding
- Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject's safe participation in and completion of the study
- Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
- Known hypersensitivity to iron dextran
- Known pre-existing human anti-mouse antibodies (HAMAs)
- ontraindication against mandatory protocol-inherent comedication(s): antihistamine and/or acetaminophen
- Failure to use highly-effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
- Oral hormonal contraception ('pill')
- Dermal hormonal contraception
- Vaginal hormonal contraception (NuvaRing®)
- Contraceptive plaster
- Long-acting injectable contraceptives
- Implants that release progesterone (Implanon®)
- Tubal ligation (female sterilization)
- Intrauterine devices that release hormones (hormone spiral)
- Double barrier methods
- This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
- Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
- Legally incapacitated persons
- Persons held in an institution by legal or official order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department I for Internal Medicine University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: A Phase I/ Randomized Phase II Trial to Analyse Safety and Efficacy of Human SARS-CoV-2-specific T Lymphocyte Transfer in Patients With COVID-19 in Need of Treatment or at Risk of Severe COVID-19
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
Read the detailed description
The clinical trial will consist of a phase I and a phase II part. The main trial objective in the phase I part is to determine the recommended phase II dose (RP2D) of viable human SARS-CoV 2-specific T cells by evaluation of safety and tolerability.
In the phase II part, the primary objective is to gain first data on efficacy of adaptive therapy with viable human SARS-CoV-2-specific T cells. This will be a randomized, prospective feasibility trial.
Details to phase II will be updated after completion of phase I.
- Conditions
- Moderate COVID-19-infection
- Being tested
- human SARS-CoV 2 specific T lymphocytes
- Keywords
- COVID-19, T-Cell, SARS-CoV-2, Infusion, Adoptive, Allogeneic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human SARS-CoV 2 specific T lymphocytesDrug
In dose level one, SARS-CoV-2 infected patients will receive 1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW.
In dose level two SARS-CoV-2 infected patients will receive 5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW.
In parallel, all patients will receive the current SoC treatment for COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | SARS CoV-2 infected participants will receive a single infusion over 15 to 30 minutes Receives: Drug: human SARS-CoV 2 specific T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose-limiting toxicities
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
Measured: 28 days
Secondary outcomes (7)
Phase I: Safety
The rate and severity of adverse events after infusion of SARS-CoV-2 specific T cells during the trial
Measured: 3 Month
Phase I: Acute graft- vs. -host disease
Clinical manifestations of acute graft- vs. -host disease at day 100 after randomization
Measured: 100 days after enrollment
Phase I: Clinical status
Clinical status as assessed on the WHO ordinal scale
Measured: 100 days after enrollment
Phase I: Hospitalization
duration in days
Measured: 100 days after enrollment
Phase I: SARS-CoV-2 PCR positivity
Duration of SARS-CoV-2 PCR positivity (in days) from nasooropharyngeal swabs until discharge or death
Measured: 100 days after enrollment
Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte
Detection of viable human SARS-CoV-2-specific T lymphocyte after infusion
Measured: 100 days after enrollment
Phase I: viral shedding in nasooropharyngeal swabs
Effect of viable human SARS-CoV-2-specific T lymphocyte infusion on viral shedding in nasooropharyngeal swabs
Measured: 100 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start8 Dec 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate COVID-19-infectionStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- This trial consist of an open-label dose escalation phase in SARS-CoV-2 infected participants.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Collaborators
- ZKS Köln, Hannover Medical School, Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor
- Investigators
- Philipp Köhler, Dr., Principal investigator, Department I for Internal Medicine University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762186
- Sponsor's protocol ID
- Uni-Koeln-4480
- Acronym
- ACT-COVID-19
- Status last verified
- Sep 2022
- First submitted
- 11 Feb 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/ Randomized Phase II Trial to Analyse Safety and Efficacy of Human SARS-CoV-2-specific T Lymphocyte Transfer in Patients With COVID-19 in Need of Treatment or at Risk of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04762186
- Acronym / sponsor ID
- ACT-COVID-19 / Uni-Koeln-4480
- Conditions
- Moderate COVID-19-infection
- Keywords
- COVID-19, T-Cell, SARS-CoV-2, Infusion, Adoptive, Allogeneic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Collaborators
- ZKS Köln, Hannover Medical School, Miltenyi Biomedicine GmbH
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 21 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.
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
Detailed description
The clinical trial will consist of a phase I and a phase II part. The main trial objective in the phase I part is to determine the recommended phase II dose (RP2D) of viable human SARS-CoV 2-specific T cells by evaluation of safety and tolerability.
In the phase II part, the primary objective is to gain first data on efficacy of adaptive therapy with viable human SARS-CoV-2-specific T cells. This will be a randomized, prospective feasibility trial.
Details to phase II will be updated after completion of phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial consist of an open-label dose escalation phase in SARS-CoV-2 infected participants.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: human SARS-CoV 2 specific T lymphocytesSARS CoV-2 infected participants will receive a single infusion over 15 to 30 minutes |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or above
- Written informed consent from the trial subject has been obtained
- Willing to follow contraception guidelines
- Tested positive for SARS-CoV-2 by PCR <72 hours after swab
- A maximum of 14 days between onset of symptoms and enrollment
Key exclusion criteria (29 listed)
- Participation in any other clinical trial of an experimental agent treatment
- Active GvHD or history of GvHD
- History of CAR-T-Cell Therapy
- COVID-19 WHO ordinal scale ≥6
- Anticipated life-expectancy <72 hours
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 |
|---|---|---|
| human SARS-CoV 2 specific T lymphocytesIn dose level one, SARS-CoV-2 infected patients will receive 1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In dose level two SARS-CoV-2 infected patients will receive 5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In parallel, all patients will receive the current SoC treatment for COVID-19. | Drug | Dose escalation |
Primary outcome
Phase I: Dose-limiting toxicities
Time frame: 28 days
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
7 secondary outcomes
Phase I: Safety
Time frame: 3 Month
Phase I: Acute graft- vs. -host disease
Time frame: 100 days after enrollment
Phase I: Clinical status
Time frame: 100 days after enrollment
Phase I: Hospitalization
Time frame: 100 days after enrollment
Phase I: SARS-CoV-2 PCR positivity
Time frame: 100 days after enrollment
Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte
Time frame: 100 days after enrollment
Phase I: viral shedding in nasooropharyngeal swabs
Time frame: 100 days after enrollment
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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.
Philipp Köhler, Dr. principal investigator
Department I for Internal Medicine University Hospital of Cologne
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 human SARS-CoV 2 specific T lymphocytes in people with Moderate COVID-19-infection, run by Universitätsklinikum Köln at 1 site in Germany.
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 13 inclusion and 29 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: stopped early, as of the sponsor's last update on 15 Sep 2022. 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 Germany. 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 stopped early (reason given: poor recruitment). Results are not available in the source record.
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?
Phase I: Dose-limiting toxicities (time frame: 28 days). 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 15 Sep 2022.