COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05447013

Evangelia Yannaki, MD, PI

eyannaki@u.washington.edu

2022-07-07

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: hospitalized patients, sars-cov-2 pcr positive, within 8 days from the onset of the symptoms (immunosuppressed patients are excluded from the time limit when they become chronic carriers of the virus), who have: pneumonia or/and sato2 ≤94% on room air or/and respiratory rate ≥24breaths/min and lymphopenia cd3+≤650/μl or/and alc≤1000/microl and increased values of d-dimers (≥2χ) or/and ferritin (>1000ng/ml) or/and crp (≥3χ) or/and ldh (≥2χ)

age ≤18 and ≥80 years old onset of symptoms >8 days (immunosuppressed patients are excluded from the time limit when they become chronic carriers of the virus) corticosteroid administration at a dose of >0.75mg/kg (methylprednisolone equivalent) multiple organ failure ards (acute respiratory distress syndrome) mechanical ventilation 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 judged ineligible by at the treating physician (treating physician's discretion) bilirubin ≥2x of upper normal limit ast ≥ 2x of upper normal limit creatinine ≥ 2x of upper normal limit or with dialysis/hemodialysis needs karnofsky score ≤50

2

George Papanicolaou Hospital

18

80

Greece

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

182

Efficacy endpoint-1 (Phase II);Efficacy endpoint-2 (Phase II);Establishment of a CoV-2-STs bank;Establishment of a CoV-2-STs bank of broad HLA coverage;Pharmacodynamic endpoint-1 (Phase I);Pharmacodynamic endpoint-2 (Phase I and II);Pharmacodynamic endpoint-3 (Phase II);Safety endpoints (Phase I and II)

None

Phase 1/Phase 2

[{"arm_notes": "nan", "treatment_id": 2560, "treatment_name": "Coronavirus-2-specific t cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]