Generation of SARS-CoV-2-specific T lymphocytes from recovered donors and administration to high-risk COVID-19 patients

Phase 1

• Conditions: COVID-19 high-risk patients; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001022-22-GR
• Lead Sponsor: Ge???? ??s???µe?? Tessa??????? Ge?????? ?apa????????

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-19
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 182

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified