I wonder if the BIT225-010 and 011 readouts will include any data that the non placebo patient had no COVID19 infection or mortality vs placebo. A COVID19 fatality in the plecebo group could do interesting things to the SP and the advancement of trials. People with HIV appear to have a slightly increased risk of dying from COVID-19. A low CD4 count increases the risk of serious illness and death from COVID19. We may have some participants with lower CD4 since one study has ART niave and the other ART failing. It would be nice to get some confirmation of COVID19 suppression before the actual COVID19 study readout.
This would be a good question to ask the company at the next opportunity.
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Ann: POSITIVE FDA GUIDANCE FOR COVID-19 CLINICAL PROGRAM, page-182
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