Paul Potnuru
The objective of this study is to assess the efficacy and safety of vadadustat for treating hospitalized patients with nonintubated Acute Respiratory Distress Syndrome (ARDS) secondary to pathogen-associated lung injury.
Inclusion Criteria: -Meets the definition of nonintubated ARDS per the 2024 Global Definition of ARDS that includes all the following (2A-2D): * 2A. Risk factors and origin of pulmonary edema: Precipitated by an acute predisposing risk factor, specifically from a suspected pathogen-associated etiology such as pneumonia\* or non-pulmonary infection\*\* \[\*Pneumonia defined as known or suspected based on treating physician documentation or discussion, OR both of the following criteria: 1) Chest radiography with new infiltrates, consolidation, or cavitation and (2) Clinical signs of pneumonia…
Participants will receive 900mg vadadustat (as oral tablets) daily for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.
Participants will receive 1200mg vadadustat (as oral tablets) daily for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.
Participants will matching placebo (as oral tablets) daily for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.
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