A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Public ClinicalTrials.gov record NCT04345614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Part 1: A Randomized Controlled Open-Label Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Severe COVID-19 Pneumonia Part 2: A Randomized Double Blind, Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia (CARDEA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04345614
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 314 participants
Conditions and interventions
Conditions
Interventions
- Auxora (Part 1) Drug
- Standard of Care (Part 1) Drug
- Auxora (Part 2) Drug
- Placebo (Part 2) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2020
- Primary completion
- Jun 27, 2021
- Completion
- Jul 29, 2021
- Last update posted
- Mar 29, 2026
2020 – 2021
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial | Long Beach | California | 90806 | — |
| University of Southern California / LA County | Los Angeles | California | 90033 | — |
| Sharp Memorial San Diego | San Diego | California | 92123 | — |
| National Jewish Health / St. Joseph's Hospital | Denver | Colorado | 80220 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Baton Rouge General | Baton Rouge | Louisiana | 70809 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sinai Grace | Detroit | Michigan | 48235 | — |
| Methodist Hospital | Saint Louis Park | Minnesota | 55426 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Texas Tech University Medical Center | El Paso | Texas | 79905 | — |
| John Peter Smith Hospital | Fort Worth | Texas | 76104 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Aurora Baycare | Green Bay | Wisconsin | 54311 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04345614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04345614 live on ClinicalTrials.gov.