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 - ACT-COVID19

niversity of Cologne0 个研究点目标入组 51 人开始时间: 2021年4月1日最近更新: 2021年11月8日

适应症

试验速览

暂无简介。

•For phase I and II
•1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent (participants = 18 years of age)
•2. Willing to follow contraception guidelines
•3. Tested positive for SARS-CoV-2 by PCR <72 hours prior to inclusion
•4. A maximum of 14 days between onset of symptoms and
•5. WHO score 4 with at least one additional risk factor for disease progression
•Acceptable risk factors are:
•a. Radiographically proven lung infiltrates
•b. Immunosuppression either by malignant disease or its treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
•c. Immunosuppressive drugs, including steroids at a prednisolone equivalent of <1 mg/kg BW. 6mg dexamethasone per os or intravenous 1x/d (SOC) are allowed, but are not considered as inclusion criterion in the sense of immunosuppressive treatment
•d. Receipt of an autologous transplant within the last 5 years
•e. Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression OR
•6. WHO score Score 5
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

•For phase I and II
•1. Participation in any other clinical trial of an experimental agent treatment
•2. Active or history of GvHD
•3. History of CAR-T-Cell Therapy
•4. COVID-19 WHO ordinal scale =6
•5. Anticipated life-expectancy <72 hours
•6. Expected duration of hospital stay <72 hours
•7. Sepsis-induced leukopenia or thrombocytopenia (leukocytes <1000/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.
•8. CT pneumonia score =13, if CT has been performed as SoC
•9. Any other Steroids = 1mg/kg Prednisolon-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
•10. Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
•11. Known hypersensitivity to iron dextran
•12. Known pre-existing human anti-mouse antibodies (HAMAs)
•13. Contraindication against mandatory protocol-inherent comedication(s): antihistamine and/or
•acetaminophen
•14. Pregnant or breast feeding
•15. 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

发起方

niversity of Cologne