Abstract
An unvaccinated adult male heart transplant recipient patient with recalcitrant COVID-19 due to SARS-CoV-2 delta variant with rising nasopharyngeal quantitative viral load was successfully treated with ALVR109, an off-the-shelf SARS-CoV-2-specific T cell therapy. Background immunosuppression included 0.1 mg/kg prednisone, tacrolimus, and mycophenolate mofetil 1 gm twice daily for historical antibody-mediated rejection. Prior therapies included remdesivir, corticosteroids, and tocilizumab, with requirement for high-flow nasal oxygen. Lack of clinical improvement and acutely rising nasopharyngeal viral RNA more than 3 weeks into illness prompted the request of ALVR109 through an emergency IND. The day following the first ALVR109 infusion, the patient’s nasopharyngeal SARS-CoV-2 RNA declined from 7.43 to 5.02 log 10 RNA copies/ml. On post-infusion day 4, the patient transitioned to low-flow oxygen. Two subsequent infusions of ALVR109 were administered 10 and 26 days after the first; nasopharyngeal SARS-CoV-2 RNA became undetectable on Day 11, and he was discharged the following day on low-flow oxygen 5 weeks after the initial diagnosis of COVID-19. The clinical and virologic improvements observed in this patient following administration of ALVR109 suggest a potential benefit that warrants further exploration in clinical trials.
Keywords: antibiotic: antiviral; clinical research/practice; heart transplantation/cardiology; immunobiology; infection and infectious agents-viral: SARS-CoV-2/COVID-19; infectious disease.
【저자키워드】 clinical research/practice, Infectious disease., infection and infectious agents-viral: SARS-CoV-2/COVID-19, immunobiology, antibiotic: antiviral, heart transplantation/cardiology, 【초록키워드】 COVID-19, Corticosteroids, therapy, Antiviral, Tocilizumab, Cell therapy, variant, Infection, Immunosuppression, High-flow nasal oxygen, Remdesivir, clinical trials, oxygen, Infectious disease, delta variant, RNA, improvement, T cell, Viral load, nasopharyngeal, male, Patient, Heart transplantation, Clinical improvement, Prednisone, SARS-CoV-2 RNA, Quantitative, tacrolimus, administration, mycophenolate, infectious agents, mycophenolate mofetil, request, rejection, low-flow oxygen, SARS-CoV-2 delta, Administered, benefit, initial, log, the patient, subsequent, Day, treated, discharged, rising, declined, diagnosis of COVID-19, IND, nasopharyngeal viral, transitioned, undetectable, 【제목키워드】 Severe COVID-19 pneumonia, therapy, HLA, treat,