COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04762186

None

None

2021-02-21

Terminated

RCT

Randomized

Sequential assignment

Open label

single-center

Treatment

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

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

2

Universitätsklinikum Köln

18

99

Germany

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1

Phase I: Dose-limiting toxicities

None

Phase 1

[{"arm_notes": "1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW.", "treatment_id": 1160, "treatment_name": "Sars-cov-2-specific t cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW.", "treatment_id": 1160, "treatment_name": "Sars-cov-2-specific t cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]