BIT225-010
The study will enrol 27 adult male and female participants who will be randomised in a 2:1 double-blinded fashion for 24 weeks, with one group receiving BIT225 (18 individuals), and one group receiving placebo (9 individuals). All participants will receive standard of care cART. An eight (8) week follow-up period on cART alone will follow the active treatment, or placebo portion of the study. At the conclusion of the trial, participants will remain on cART as per standard treatment protocols.
BIT225-011
Study Design: The study will enrol 20 adult male and female participants.
All will continue their ongoing cART regimen,
and all will receive 12 weeks of BIT225.
BIT225-012 (unsure of how many participants)
The Phase 2, double blind, placebo-controlled clinical trial aims to determine if 7 days of treatment with BIT225 commenced within 3 days of onset of COVID-19 symptoms results in reduction in SARS-CoV-2 blood viral load,
clinically favourable changes in viral,
inflammatory and immune activation markers,
as well as improvement in clinical symptoms of COVID-19.
As you stated additional Sites were added,
Although not sure if that meant additional patients,
Or just some didn't have to travel as far,
Due to the additional new Sites.
The other thing is during the BIT225-009 Trials,
BIT had to develop it's own new cutting edge Assays,
that themselves would have enormous value in being able to test
that compounds tested target and kill virus that hides in long-lived reservoir cells:
"“No one has done this before, and there were no guidelines to follow. We have had to use a range of techniques to show that BIT225 has done what we expected it to do i.e. clear out virus from these reservoirs. This has included the development and use of new cutting-edge assays, which has been a time-consuming process."
So now that all of the Phase II Trials have been completed,
It's just waiting for the results
And potential Offers / Take-Over Bids
From Multinational Pharmaceutical Companies....
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