Moderate COVID-19-infection Clinical Trial
— ACT-COVID-19Official 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
| Verified date | September 2022 |
| Source | Universitätsklinikum Köln |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | August 3, 2022 |
| Est. primary completion date | August 3, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - 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 - 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 Exclusion criteria: - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department I for Internal Medicine University Hospital of Cologne | Cologne | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| Universitätsklinikum Köln | Hannover Medical School, Miltenyi Biomedicine GmbH, ZKS Köln |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase I: Dose-limiting toxicities | Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells | 28 days | |
| Secondary | Phase I: Safety | The rate and severity of adverse events after infusion of SARS-CoV-2 specific T cells during the trial | 3 Month | |
| Secondary | Phase I: Acute graft- vs. -host disease | Clinical manifestations of acute graft- vs. -host disease at day 100 after randomization | 100 days after enrollment | |
| Secondary | Phase I: Clinical status | Clinical status as assessed on the WHO ordinal scale | 100 days after enrollment | |
| Secondary | Phase I: Hospitalization | duration in days | 100 days after enrollment | |
| Secondary | Phase I: SARS-CoV-2 PCR positivity | Duration of SARS-CoV-2 PCR positivity (in days) from nasooropharyngeal swabs until discharge or death | 100 days after enrollment | |
| Secondary | Phase I: Detection of viable human SARS-CoV-2-specific T lymphocyte | Detection of viable human SARS-CoV-2-specific T lymphocyte after infusion | 100 days after enrollment | |
| Secondary | Phase I: viral shedding in nasooropharyngeal swabs | Effect of viable human SARS-CoV-2-specific T lymphocyte infusion on viral shedding in nasooropharyngeal swabs | 100 days after enrollment |