From the announcement on 1 September:
A range of doses of Veyonda® will be administered to patients hospitalised with moderate symptoms who are at high risk of tipping over into a cytokine storm and developing septic shock. Typically, these patients are sick enough to require hospitalisation, but do not yet have such severe symptoms that they require ICU care or mechanical ventilation.
The safety and tolerability of the medication in patients with poor lung function will be measured, as well as the drug’s ability to prevent patients progressing into a cytokine storm and septic shock. One of the key endpoints is the effect of treatment on blood cytokine levels, which will be assayed in an Australian laboratory.
Noxopharm remains in discussion with the U.S. FDA on conducting a clinical study in the U.S., with NOXCOVID-1 serving as a pilot, proof-of-principle study.
So, NOXCOVID-1 is a proof-of-principle, dose-escalation, open-label trial treating moderately-ill patients who do not (yet) require ICU care and which, if successful, would be followed by a larger randomized trial. We have not seen the protocol, but it seems inconceivable that Noxopharm would allow concurrent treatment with confounding agents such as dexamethasone.
I have a feeling that NOX will keep us informed.
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From the announcement on 1 September: A range of doses of...
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