COVID-19 high-risk patients
Conditions
Interventions
Product Name: SARS-COV-2 e?d??? ?-?eµf???tta?a
Product Code: COV-2-STs-001
Pharmaceutical Form: Solution for injection
Sponsors
Ge???? ??s???µe?? Tessa??????? "Ge?????? ?apa????????"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · PCR positivity in SARS-CoV-2 · Age =18 =80 years · Pneumonia and / or SatO2 =94% in air and / or respiration =24 / min 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 109 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 73
Exclusion criteria
Exclusion criteria: -Age =18 and =80 years old -?o need for hospitalization/ O2 -Corticosteroid administration at a dose of >0.75mg/kg (methylprednisolone equivalent) -Multiple organ failure -ARDS (acute respiratory distress syndrome) -Patients who received ATG, or Campath, or other T-cell-suppressing monoclonal antibody within 28 days prior to admission -Patients with concomitant confirmed infection from another pathogen or with very high procalcitonin (PCT) that may indicate additional infection -Enrollment in another clinical trial -Pregnancy -Inability to sign informed consent form (except the case of an intubated patient in which A¨degree relative signs the informed consent form) -Judged ineligible by at the treating physician (treating physician’s discretion) -AST = 3x of upper normal limit -Creatinine = 2x of upper normal limit or with dialysis/hemodialysis needs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: I) To determine the feasibility of establishing a bank with GMP-compliant generated SARS-CoV-2 specific T-cells (CoV-2-STs), well-characterized in terms of specificity, phenotype and expression of human leucocyte antigens (HLA), which will be produced by 30 COVID-19 recovered donors with broad HLA diversity in order to be suitable for administration to at least 90 COVID-19 patients II) To determine the safety of CoV-2-ST administration as cellular immunotherapy in COVID-19 patients, who meet specific inclusion criteria III) To determine the efficacy of CoV-2-ST administration as cellular immunotherapy in COVID-19 patients, who meet specific inclusion criteria ;Secondary Objective: -Expansion of CoV-2-STs, defined as the absolute number of measured CoV-2-STs in the circulation relative to the reference point (d0) in Brach-A and –B, on days 5, 10, 15, 20, 30, 60 - Clinical status at day 30 and day 60 (survival without disease, survival with disease, death) - Time to improve in the Ordinal Scale by 1 and by 2 categories from day 0 - PCR negative time - Percentage of patients with PCR negativity on day 30 - Lymphopenia recovery time - Duration of stay of CoV-2-STs in circulation - Time from day 0 until discharge - Time from day 0 until full restoration of physical function;Primary end point(s): GMP endpoints of COV-2-STs production and bank creation: • Capable of producing 30 CoV-2-ST cell lines, each of which will be able to cover at least 3-4 patients • Release rate of cell products produced (CoV-2-STs) • Failure to find a suitable HLA product in =5% of patients Pharmacodynamic endpoints (Phase I): • Determination of the optimal dose Expansion of CoV-2-STs after injection • Residence of CoV-2-STs in circulation Efficiency endpoints (Phase II): - Recovery and Recovery time, defined as the first day after randomization (Brach-B, dm.0) or cell administration (Brach-A, dm.0) and within 30 days, during which the patient meets the criteria for classifi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficiency Endpoints (Phase II) Secondary: -Development of CoV-2-STs, defined as the absolute number of measured CoV-2-STs in circulation relative to the reference point (nm0) at Brach-A and -B, on days 5, 10, 15, 20, 30 , 60 -Clinical condition on day 30 and day 60 (survival without disease, survival with disease, death) -Improvement time in the Ordinal Scale by 1 and by 2 categories from on the day.0 - PCR negative time -Percentage of patients with PCR negative on day 20 -Recovery t imeof lymphopenia -Stay of COV-2-STs in circulation -Time from day 0 until departure -Time from day 0 until the complete restoration of the physical operation Safety terminals Secondary: • Graft-vs-host-disease / GvH;Timepoint(s) of evaluation of this end point: Day 20 or day 30 where applicable | — |
Countries
Greece
Contacts
Public ContactG?a????? ??a??e??a
??µat??????? ???????, ????da ?etaµ?s?e?s?? ??µ?p???t???? ??tt????, ??s???µe?? G. ?apa????????, Tessa??????
Outcome results
None listed