Biotech Values

[DewDiligence]

OPK—Those COVID-19 data look spectacular—probably too good to be real insofar as the drug being tested, Calcifediol, is simply a vitamin-D analog.

An obvious criticism of the trial is that some of the strongest baseline risk factors for severe COVID-19 disease were higher in the placebo arm than the Calcifediol arm:


• The Calcifediol arm was 46% male, while the placebo arm was 69% male;

• The Calcifediol arm had 6% type-2 diabetics, while the placebo arm had 19% type-2 diabetics; and

• The Calcifediol arm had 24% hypertensive patients, while the placebo arm had 57% hypertensive patients.


Further, the background therapy given to patients in both trials arms may have had a confounding effect:

All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400?mg every 12?hours on the first day, and 200?mg every 12?hours for the following 5 days), azithromycin (500?mg orally for 5 days) and for patients with pneumonia and NEWS score=5, a broad spectrum antibiotic (ceftriaxone2 g intravenously every 24?hours for 5 days) was added to hydroxychloroquine and azithromycin.

To reiterate, the top-line data from this trial seem too good to be true.