OPKO Health Announces Topline Data from Phase 2 Trial of Rayaldee in Treating Mild-to-Moderate COVID-19, Supporting the Use of Vitamin D Repletion Therapy

by | Dec 23, 2021 | Featured, Integrative Therapies

OPKO Health announced preliminary topline results from its Phase 2 trial with Rayaldee to treat mild-to-moderate COVID-19. Preliminary data indicate that improving vitamin D status with oral Rayaldee results in earlier resolution of respiratory symptoms associated with COVID-19. Following oral administration, Rayaldee 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. 

The randomized, double-blind, placebo-controlled phase 2 study, RESCUE, was designed to evaluate Rayaldee (calcifediol) Extended-release capsules to treat symptomatic patients infected with SARS-CoV-2. A total of 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. The average age of enrolled subjects was 43. Nearly 40% were obese and 79% overweight, based on body mass index (BMI) greater than 30 or 25, respectively. Approximately 30% had comorbidities.

The first primary efficacy endpoint, reaching the targeted serum 25D level, was reached. By Day 7, mean serum 25D levels increased with Rayaldee treatment to 82 ng/mL and remained elevated for the duration of the trial, with 88% of subjects attaining the targeted level. In contrast, mean 25D declined slightly with placebo treatment.

A second primary efficacy endpoint was the benefit of raising serum 25D on the time to resolution of five COVID-19 symptoms: trouble breathing, chest congestion, dry or hacking cough, body aches and pains, and chills and shivering. The three symptoms related to respiratory function, evaluated together, resolved more quickly when serum 25D was elevated at Days 7 and 14, with resolution of chest congestion occurring 3.4 days sooner. In subjects achieving increases in serum 25D of at least 25 ng/mL, chest congestion resolution occurred 4 days earlier. 

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