Preliminary data indicate that improving vitamin D status with oral RAYALDEE results in earlier resolution of respiratory symptoms associated with COVID-19
MIAMI, Dec. 23, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) announces preliminary topline results from its Phase 2 trial with RAYALDEE® to treat mild-to-moderate COVID-19. This study builds on increasing medical evidence that vitamin D repletion therapy can mitigate the severity of upper respiratory tract infections and accelerate recovery from COVID-19.
RAYALDEE, after oral administration, gradually releases calcifediol, the natural storage form of vitamin D3, to safely and reliably raise a patient’s serum total 25-hydroxyvitamin D (25D) well above current targets of 20 or 30 ng/mL. RAYALDEE is approved in the U.S. and many European countries for treating secondary hyperparathyroidism in non-dialysis chronic kidney disease (CKD) patients by raising 25D to levels as high as 100 ng/mL.
In the Phase 2 trial, titled “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),” 171 symptomatic COVID-19 outpatients were enrolled from multiple U.S. sites and randomized in a 1:1 ratio for 4 weeks of treatment with RAYALDEE or placebo and a 2-week follow-up. Dosing with RAYALDEE was designed to progressively raise serum 25D to 50 to 100 ng/mL by Day 7, beginning with 300 mcg on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. COVID-19 symptoms were self-reported daily during the 42-day study using the FLU-PRO Plus© questionnaire, an outcome tool validated for upper respiratory tract infections. Blood samples and safety assessments were obtained at 7-day intervals.
One primary efficacy endpoint was reaching the targeted serum 25D level. By Day 7, mean serum 25D levels increased with RAYALDEE treatment to 82 ng/mL (p