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OPKO Announces Positive Results From Phase 2 Trial Of Rayaldee On Symptomatic COVID-19 Treatment

OPKO Health Inc. (OPK) announced preliminary positive results from its Phase 2 trial with Rayaldee to treat mild-to-moderate COVID-19. The preliminary data indicated 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 25-hydroxyvitamin D to levels as high as 100 ng/mL.

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 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.

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