Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19

- 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:

- 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:

- 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