Clinical Trials


Auxora for COVID-19 and Acute Respiratory Failure

In April 2020, we initiated a clinical trial to test Auxora in COVID-19 patients hospitalized and requiring oxygen therapy but not on ventilators. This trial was initially conducted as a Phase 2 randomized, open-label clinical trial in severe COVID-19 pneumonia patients with varying degrees of respiratory failure where time to survival, blood oxygen levels, ventilator use and mortality were evaluated. At our first safety analysis of the data we observed that patients receiving Auxora with SOC were less likely to be placed on mechanical ventilation or to die, and they experienced a reduced time to recovery than those treated with SOC alone. After 30 patients were enrolled in this first part of the trial (Part 1), the U.S. Food and Drug Administration recommended that we move to Part 2 of the trial and study Auxora in a blinded, placebo-controlled trial.

Part 2 was initiated in September 2020, and we have now completed enrollment of 284 severe COVID-19 pneumonia patients in this randomized, double-blind, placebo-controlled clinical trial. We completed Part 2 in the third quarter of 2021. We observed that patients treated with Auxora experienced a reduced time to recovery, higher rate of recovery and reduced mortality.

For more details on the clinical trial, please visit A Study of Auxora in Patients With Severe COVID-19 Pneumonia and the Critical Care papers published in 2020 and 2022.

Information on our Expanded Access Policy can be obtained through the following link.

In addition to the study in COVID-19 pneumonia patients receiving oxygen therapy, we are conducting a Phase 2 randomized open-label, placebo-controlled dose escalation trial of Auxora in mechanically ventilated patients with COVID-19 pneumonia to determine an effective dose of Auxora for treating these patients using pharmacodynamic markers from bronchoalveolar lavage fluid. This study is being conducted by researchers at Northwestern University who have published their work elucidating the mechanism of SARS-COV2 pathology in the lungs of COVID-19 pneumonia patients (Grant et al., Nature January 2021). Patients have received either Auxora or placebo for three or four days, or an initial infusion followed by four days of continuous infusion. The amount of time that patients remain on the ventilator is measured as part of the trial. Lung lavages are taken to determine the level and activity of macrophages, monocytes and IFNγ-secreting T cells in patients receiving drug and placebo. Enrollment for this trial was recently completed. We anticipate this trial will be completed by the end of 2022. We plan to use the findings of this clinical trial to establish an effective dosing schedule for further studies of Auxora in the treatment of ventilated ARDS patients.

For more details on the clinical trial, please visit: A Study of Auxora in Patients With Critical COVID-19 Pneumonia.

Information on our Expanded Access Policy can be obtained through the following link.

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