ABSTRACT
Purpose The aim of this study was to describe the clinical course and outcomes of four lung transplant recipients in the CD10 trial (NCT04343651): use of leronlimab (PRO 140), a novel humanized IgG4,κ monoclonal antibody to CCR5, for the treatment of mild-moderate COVID-19 illness. Methods Four eligible lung transplant recipients with positive SARS-CoV2 PCR testing and mild-moderate illness received placebo or 1-2 weekly 700mg subcutaneous doses of leronlimab. Demographics, laboratory, radiologic, and clinical outcomes were reviewed. Results Between March and May 2020, three single-lung transplant recipients received leronlimab and one received placebo for mild-moderate disease. The total median age was 63.5 years (range 59.0-73.0) with equal male and female participants. The median duration between transplant and COVID-19 diagnosis was 409 days (range 149-631). Three patients (75%) required hospitalization for a median of 3 days (range 2-4);however, none required mechanical ventilation or positive pressure support. Baseline median CRP and CD4/CD8 counts were 4.4 mg/dL (range 1.3-15.3) and 1.16 (range 0.73-1.84) respectively, and normalized after one week of therapy. Abnormal imaging findings at the time of diagnosis were identified in native lungs (Figure 1). Baseline median FEV1, FVC, and 6MWT were 2.07 L (range 0.76-3.4), 2.73 L (range 1.46-4.09), and 402 m (range 247-496) with median change in baseline of -1.7%, -2.8%, and 3.8% respectively as of full clinical recovery through September 1, 2020. There were no episodes of acute rejection, by clinical evaluation or biopsy, or other known adverse events noted after leronlimab administration. Conclusion No definitive adverse events, disruptions of immunosuppression, or episodes of acute rejection or BOS were identified following leronlimab administration in a small series of lung transplant patients. Leronlimab may prove a safe and effective therapy for the restoration of immune homeostasis associated with COVID-19 illness in the future.