The inclusion of steroids in late July most likely also slowed Recruitment.
The WHO review concluded corticosteroids reduced deaths in critically ill patients by 20 percent — a drop from 2 deaths per 5 patients to 1 in 3.
The Recovery trial did not observe a benefit in patients with mild covid-19.
Trial steering committees around the world concluded it would be uncomfortable, if not unethical, for doctors to give patients placebos in randomized trials. Because of that, these steroid trials stopped short of enrolling enough patients for their results to be as statistically powerful as desired.
Hi Kiwi. First wanted to ask how you are doing with the fires all around out west? I see the Air Quality Index is very bad in many places.
Secondly are you beginning to think about reducing your position here if we don’t hear anything about the IV trial soon? It somewhat bothers me when companies go on radio silence.
Also look at what the Chairman has said with regards to Phase IIb/III trials in a recent interview:
Let’s focus on the US: That is a Phase IIb/III trial that is aimed at patients who are severely ill because of the consequences of Covid-19. Assuming we have positive, statistically significant data, we would be in a position to go to the FDA and ask for approval. There is also a potential way to get approval sooner: This is by presenting the FDA clear evidence that the drug is therapeutically meaningful effective in a so-called compassionate access program. Having been granted the permission by the FDA to conduct such a compassionate access program, we are currently in this program. The study we are running has registrational quality. If it would be successful it could be the basis for a FDA approval.