THIS IS HUGE - ALL PATIENTS SURVIVED AGE 71
Each of the patients enrolled in this emergency use program was showing active signs of clinical deterioration at the
time of enrollment despite receiving maximal intensive care for COVID-19 related respiratory failure at the Houston
Methodist Hospital. The median age of patients was 71 (Interquartile range [IQR] = 25 years) and there were 3 male
and 3 female patients (Table 1). All patients had known chronic diseases. The most common comorbidities prior to
admission were hypertension (4/6) and chronic kidney disease (4/6). Two patients have known diabetes mellitus, with
Patient 6 being insulin-dependent. Three of the patients had undergone solid organ transplants and were treated with
immunosuppressive agents. Patient 2 received a double lung transplant and was treated for antibody-mediated
rejection (AMR) one month before presentation. Patient 1 was also diagnosed with a non-ST-elevation myocardial
infarction (NSTEMI) during her admission (Table 1). All patients had lab values suggestive of diffuse inflammatory
processes including elevated ferritin (5/6), IL-6 (4/6), lactate dehydrogenase (3/6), and C-reactive protein (3/6).
Prior to enrollment, all patients received anticoagulation as well as dexamethasone without remission from respiratory
failure. Patients were also treated with remdesivir, tocilizumab, and convalescent plasma as available and per
physician discretion. However, supply shortages of these agents were such that only Patient 1 received convalescent
plasma before Aviptadil with no clinical improvement following treatment. Following enrollment and informed
consent, each patient received three 12-hour intravenous infusions of Aviptadil at graduating doses of 50, 100, and
150 pmol/kg/hr.
