A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Summary
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 of this study randomized 284 patients and was a randomized, double blind, placebo-controlled (RCT) study that evaluated the efficacy, safety, and the pharmacokinetic profile of Auxora in patients with severe COVID-19 pneumonia. The number of patients with an imputed PaO2/FiO2 \>200 randomized into the study was capped at 26. Another 258 patients with a PaO2/FiO2 ≤200 were enrolled. Patients with an estimated PaO2/FiO2 of 75-200 were stratified to ensure balanced randomization between the Auxora and placebo arms. Subgroup analyses were performed to explore how time to recovery is influenced by baseline variables and to evaluate the treatment effect at different levels of each of these variables. The dose of Auxora was 2.0 mg/kg (1.25 mL/kg) administered at 0 hour, and then 1.6 mg/kg (1 mL/kg) at 24 hours and 1.6 mg/kg (1 mL/kg) at 48 hours from the SFISD. The dose of placebo was 1.25 mL/kg administered at 0 hour and then 1 mL/kg at 24 hours and 1 mL/kg at 48 hours from the SFISD. Remdesivir, corticosteroids and convalescent plasma were allowed. The infusion of Auxora / Placebo started within 12 hours from the time the patient or LAR provided informed consent. Efficacy analyses will be presented by treatment group (Auxora vs Placebo) based on the Efficacy Analysis Set of the imputed PaO2/FiO2 ≤200 subgroup, except where it is specified otherwise. The statistical analysis approach was designed to assess the significance of the primary and first secondary endpoint using the Benjamini and Hochberg method to control the overall trial level alpha level.
Timeline
- Start
- 2020-04-08
- Primary completion
- 2021-06-28
- Completion
- 2021-07-30
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
release “showing substantially improved outcomes with Auxora™ (formerly called CM4620-IE) as a treatment for severe COVID-19 pneumonia” reads as met primary endpoint calcimedica.com ↗
release “Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora” reads as met primary endpoint calcimedica.com ↗
release “Time to recovery was seven vs. ten days (P = 0.0979) for patients who received Auxora vs. placebo, respectively.” reads as missed primary endpoint calcimedica.com ↗
release “In the 261-patient efficacy dataset, the median time to recovery was seven days for Auxora-treated patients compared to 10 days for placebo-treated patients [p=0.098]” reads as missed primary endpoint calcimedica.com ↗
Publications
- Bruen C, Al-Saadi M, Michelson EA, Tanios M, Mendoza-Ayala R, Miller J, Zhang J, Stauderman K, Hebbar S, Hou PC. Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial. Crit Care. 2022 Apr 8;26(1):101. doi: 10.1186/s13054-022-03964-8.
- Miller J, Bruen C, Schnaus M, Zhang J, Ali S, Lind A, Stoecker Z, Stauderman K, Hebbar S. Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial. Crit Care. 2020 Aug 14;24(1):502. doi: 10.1186/s13054-020-03220-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Auxora | Unknown | 1.6 mg/kg | Intravenous |