A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia

Summary

Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora. Patients who continue to have severe hypoxemic respiratory failure at 48 hours will be randomized to receive three additional doses of Auxora or three doses of placebo. All patients will be followed for 60 days after enrollment into the study.

Timeline

Start

2022-01-24

Primary completion

2022-07

Completion

2022-07

Outcome

Outcome not reported

Stopped (Enrollment): “lack of sufficient numbers of critically ill patients to enroll the study”

Drugs

Indications