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A Study of Auxora in Patients With Severe COVID-19 Pneumonia
NCT04345614 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Auxora (Part 1)
- DRUG Standard of Care (Part 1)
- DRUG Auxora (Part 2)
- DRUG Placebo (Part 2)
Study Locations (17)
California
- Long Beach Memorial — Long Beach
- University of Southern California / LA County — Los Angeles
- Sharp Memorial San Diego — San Diego
Texas
- Texas Tech University Medical Center — El Paso
- John Peter Smith Hospital — Fort Worth
- Houston Methodist Hospital — Houston
Michigan
- Henry Ford Hospital — Detroit
- Sinai Grace — Detroit
Minnesota
- Methodist Hospital — Saint Louis Park
- Regions Hospital — Saint Paul
Colorado
- National Jewish Health / St. Joseph's Hospital — Denver
Illinois
- Northwestern University — Chicago
Louisiana
- Baton Rouge General — Baton Rouge
Maine
- Maine Medical Center — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2020-04-08 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04345614
The ClinicalTrials.gov registry entry for NCT04345614 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CalciMedica, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pneumonia appearing as the primary indexed condition, and to 4 interventions — of which Auxora (Part 1) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04345614 reports 17 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04345614 about?
NCT04345614 is a clinical study titled "A Study of Auxora in Patients With Severe COVID-19 Pneumonia". 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 ...
What is the current status of trial NCT04345614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2020-04-08. Estimated completion is 2021-07-30.
What conditions does trial NCT04345614 study?
This clinical trial studies the following conditions: Pneumonia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04345614?
The interventions under investigation include: Auxora (Part 1) (DRUG), Standard of Care (Part 1) (DRUG), Auxora (Part 2) (DRUG), Placebo (Part 2) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04345614?
This trial is sponsored by CalciMedica, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04345614 being conducted?
This trial has 17 study locations across California, Colorado, Illinois, Louisiana, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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