Finding studies
Finding studies
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Lead
Adamis Pharmaceuticals Corporation
Phase 2/3 Adaptive, Randomized, Double-blind, placebo-controlled enrolling high risk subjects with early COVID19 infection with a primary endpoint of limiting hospitalization. As part of the initial phase 2 portion of the study, 50 COVID positive subjects with comorbidities will be enrolled. Eligible subjects positively diagnosed COVID-19 infection will be randomized 1:1 to receive either Tempol or placebo. An interim analysis by a DSMB will examine safety and markers of systemic inflammation during a Stage 1 interim analysis. Based on the DSMB adjudication, the Phase 3 portion of the trial will begin with a second interim analysis after enrollment of 124 subjects This protocol will seek to enroll approximately 248 subjects \> 18 years of age diagnosed with COVID-19 infection. All subjects will receive standard of care. As standard of care can vary between institution over time for the treatment of COVID-19; Off label medication use, therapies, devices, and interventions used in standard of care practice for COVID-19 is allowed.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
