Abstract #1002919: Endocrine Therapy for COVID19: A Randomized Pilot Study Using Calcitriol

Abstract

The systemic illness associated with SARS-CoV-2 infection results in hospitalization rate of 380.3 hospitalizations per 100,000 population, overwhelming health care systems. Some emerging therapies demonstrate modest benefits with early administration, but use is not feasible in large inpatient numbers. Vitamin D regulates expression of approximately 11,000 genes spanning many physiologic functions that include regulation of both innate and adaptive immune function, pulmonary cytokine release, and induction of autophagy as an immune defense. Hospitalized and severely ill patients exhibit high rates of vitamin D deficiency. Activation of vitamin D-dependent pathways may provide clinical benefit to patients with SARS-CoV-2 infection. We investigate potential benefit of calcitriol therapy given to patients hospitalized with COVID-19. This is an open label, randomized clinical trial of calcitriol or no treatment given to hospitalized adult patients with COVID19. Subjects were randomly assigned treatment with calcitriol 0.5 mcg daily for 14 days or hospital discharge; or no treatment (1:1) at time of enrollment. The remainder of treatment was per hospital protocol and may include remdesivir, dexamethasone, as well as supplemental 02. The primary end point was length of stay. Secondary endpoints include the need for ICU, need for oxygen step up therapy, death, and hospital readmission. Patients were excluded if they are admitted directly to the ICU, if they had hypercalcemia, hyperphosphatemia on admission, if they had disorders of calcium metabolism, chronic renal insufficiency with glomerular filtration rate < 30 ml/min, or if they are prescribed calcitriol for any reason outside of the study. We enrolled 50 consecutive patients, 25 per trial arm. The average length of stay was 5.5 (± 3.9) days in the calcitriol group compared to 9.24 (± 9.4) in the control group (p= .39). The need for ICU transfer was 8 in the control group and 5 in the calcitriol group. There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group. When comparing the oxygen saturation (sa02/Fio2 ratio) on admission and discharge between the groups the control group had an average increase of +3 on discharge and the calcitriol group had an increase of +22.8. This pilot study illustrated the potential for calcitriol use in the treatment of COVID-19 and illustrates the need for a larger randomized clinical trial. Promising results included the length of stay and improvement in oxygenation. Multiple potential mechanisms through activation of vitamin D responsive pathways warrant further study.