COVID-19 - Emergency IND

Brief description of study

This is a prospective multicenter registry with an embedded open-label randomized clinical trial to determine the effects of standard of care treatment vs. standard of care plus AT-001 on cardiac structure and function and in-hospital survival in patients hospitalized for management of COVID-19 infection. Eligible subjects with COVID-19 infection will be identified at the time of hospital admission based on existing infection control surveillance protocols, and will have clinical data extracted from the electronic medical record to determine clinical characteristics associated with cardiac structure and function and in-hospital survival. A subset of patients with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease will be treated in an open-label fashion to receive an investigational aldose reductase inhibitor, AT-001 plus standard of care. The primary objective of the interventional study is to provide emergency access to open-label treatment to COVID-19 patients with acute cardiopulmonary symptoms.

Clinical Study Identifier: s20-00416 Identifier: NCT04365699

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