The OPKO trail is randomized double-blind placebo-controlled study in approximately 160 subjects, including many with Stage 3 or 4 chronic kidney disease. The result from FAIR Health analyzing private insurance data found that CKD and kidney failure were the most common comorbidities among patients hospitalized with COVID-19. Enrolled subjects will be treated daily for four weeks and monitored out even for another two weeks. Subject designed with the RAYALDEE treatment arm will receive a loading dose of 300 micrograms on each of the first three days of treatment, followed by a maintenance dose of 60 micrograms for the remaining 24 days.
There are two primary efficacy endpoints, time to resolution of COVID-19 symptoms and consistent attainment of serum total 25 hydroxyvitamin D levels greater than or equal to 50 nanograms per ml during the last week of treatment. The study is expected to begin enrolling subjects later this quarter.
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