OPKO Health Initiates Clinical Trial of RAYALDEE in COVID-19 Patients

MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces the initiation of a Phase 2 trial with RAYALDEE as a treatment for mild-to-moderate COVID-19.  The trial, “A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue),” is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.

The trial will be conducted at multiple COVID-19 outpatient clinics in the U.S.  The initial sites are located primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest. The first subjects are expected to be enrolled within the next few weeks.

The REsCue trial will randomize COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up. Dosing with RAYALDEE will commence with 300 mcg per day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. Primary efficacy endpoints are raising and maintaining serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL and time to resolution of COVID-19 symptoms.  Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation below 94%, need for and duration of hospitalizations, requirement for mechanical ventilation, mortality rate, and severity and duration of illness evidenced by quality-of-life measures.  More information about this trial will soon become available on https://clinicaltrials.gov/.

Numerous independent studies have reported a correlation between vitamin D status and COVID-19 risk and severity.  OPKO expects to report topline results from this Phase 2 trial before year-end.

About RAYALDEE

RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D₃.  The product is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH).  RAYALDEE, approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in November 2016.