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Tuesday, December 22, 2020 7:34:47 AM
Part 1 Results
The primary objective of part 1 of the dose-ranging study was to evaluate the safety of galidesivir. No safety signals were identified, and all three dose levels were equally safe.
Secondary objectives were to evaluate the effect of galidesivir on the clinical course of COVID-19 and on SARS-CoV-2 infection in the respiratory tract.
Galidesivir treatment was associated with a more rapid decline in viral RNA levels in the respiratory tract in an apparent dose-dependent manner.
A separate study of galidesivir in a COVID-19 animal model showed that early administration of galidesivir reduced SARS-CoV-2 viral burden in lung tissue (1.4-1.6 log lower tissue viral burden) and was associated with a significant reduction in damage to lung tissue, compared to vehicle control treated animals. These results suggest that early antiviral treatment of SARS-CoV-2 infection may protect against developing severe COVID-19 lung disease.
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