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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Köln
• Collaborators: Miltenyi Biomedicine GmbH; MMH Institute for Transfusion Medicine; ZKS Köln

Criteria

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

• 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 for example 6mg dexamethasone per os or intravenous 1x/d (SoC) and steroids at a prednisolone equivalent of <1 mg/kg BW) are allowed

• Autologous transplant during the past 3 months

• Allogeneic transplant during the past year or ongoing immunosuppression or chronic Graft-versus-Host Disease

Exclusion criteria:

• Participation in any other clinical trial of an experimental agent treatment for COVID-19

• COVID-19 WHO ordinal scale ≥6

• Anticipated life-expectancy <72 hours

• Expected duration of hospital stay <72 hours

• Leukocytes <1000/µl or platelets <50.000/µl unless resulting from underlying disease or it's treatment

• CT pneumonia score ≥13 [50]

• Any other Steroids ≥ 1mg/kg Prednisolone-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d (Standard of Care)

• 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

• 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

[not yet final]