The trial will be a randomized double-blind placebo-controlled study that is expected to enroll about 160 subjects. Many of the participants will have stage 3 or 4 kidney disease and are at higher risk for developing more serious illness.
The trial will randomize outpatients in a 1:1 ratio for four weeks of treatment with rayaldee or placebo, with another two weeks of follow-up.
One primary endpoint of the trial is the time to resolution of a patient's coronavirus symptoms.
Secondary endpoints for the trial include incidence of emergency-room or urgent-care visits, oxygen saturation below 94%, need for and duration of hospitalizations, requirement for ventilators, mortality rate, and severity and duration of illness evidenced by quality-of-life measures.
Over the weekend, Pfizer’s chief executive, Albert Bourla, said that the New York health-care giant could start to distribute its coronavirus vaccine to Americans before year-end if the vaccine is found to be safe and effective.
The company expects to have enough data from its late-stage vaccine trial for the Food and Drug Administration at the end of October.
Bourla spoke to CBS’s “Face the Nation” over the weekend.
If Pfizer's drug is cleared by the FDA, the company is prepared to distribute “hundreds of thousands of doses.”
Opko shares at last check were 6% higher at $3.36.