ORCHID clinical trial to test efficacy of Hydroxychloroquine – my take

[sharoncrayn]

Mass Gen (USA) will undertake a phase 3 (random with placebo control, dose for 5 days, 800 mgs at first then tapered, status measured at day 15 to 28) with 510 seriously infected and hospitalized patients to determine the efficacy of HCQ to be completed by April 2021. I would say this is the first "big time" study on HCQ by a world class, premier medical facility that I have seen to date.

I like the quick start up (assuming recruitment isn't a problem) and the approach in general, but I have some concerns in terms of extrapolating the results:

#1 They will take only hospitalized patients instead of contrasting pre hospitalization versus hospitalized (HCQ may be only effective pre hospital which is still a positive).

#2 They will use only a fake placebo instead of something like a combination of Vitamin C, Vitamin D, and Zinc, of even HCQ plus zinc. This approach is a waste of resources and possible options.

#3 exclusion of QTc >500 ms on electrocardiogram within 72 hours prior to enrollment ( a flaw for obvious reasons which cannot be removed, but it implies they are essentially eliminating HCQ for CVD patients following FDA guidelines)

#4 no stratification for typical hospitalization cohorts (i.e. age, gender, comorbidity/underlying illness). This lack of stratification is not realistic.

[PDConscience]

By limiting it to subjects already "hospitalized/seriously infected" versus a more timely intervention at point of symptomatic indicators/confirmed diagnosis (as many doctors/researchers advise), it almost sounds like the kind of study that a Biotech with a pricy therapeutic candidate might sponsor in order to stifle a pesky off-patent rival (i.e., Gilead & proxies).

[sharoncrayn in reply to PDConscience]

It is possible. Lots of game playing and behind the curtain deals as companies rush to be the first with a "reputable" drug. It makes you wonder what their priorities are...the almighty dollar or people.