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

This is an interventional treatment trial for Moderate COVID-19-infection focused on measuring COVID-19, T-Cell, SARS-CoV-2, Infusion, Adoptive, Allogeneic Read More

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