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NCT04661540 · ClinicalTrials.gov registry record · Phase 2
A Study of Auxora in Patients With Critical COVID-19 Pneumonia
A Phase 2 study, sponsored by CalciMedica.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04661540: Clinical Trial Phase 2 study, sponsored by CalciMedica.
NCT04661540 is a Phase 2 study that was terminated before completion, run by CalciMedica. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04661540, a Phase 2 study, was terminated before completion, sponsored by CalciMedica.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a single-blind study of Auxora in patients with critical COVID-19 pneumonia, consisting of up to 3 cohorts of escalating dose. The main goal was to assess pharmacodynamic parameters of immune response, while also assessing safety and tolerability of the drug in this patient population.
Primary Outcome
Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell po
Interventions
- DRUG Placebo
- DRUG CM4620-IE (Injectable Emulsion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2021-12-21 |
| Phase | Phase 2 |
Why NCT04661540 stopped before completion
NCT04661540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04661540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04661540 about?
NCT04661540 is a clinical study titled "A Study of Auxora in Patients With Critical COVID-19 Pneumonia". This is a single-blind study of Auxora in patients with critical COVID-19 pneumonia, consisting of up to 3 cohorts of escalating dose. The main goal was to assess pharmacodynamic parameters of immune response, while also assessing safety and tolerability of the drug in this patient population.
What is the current status of trial NCT04661540?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-03-02. Estimated completion is 2021-12-21.
What interventions are being tested in trial NCT04661540?
The interventions under investigation include: Placebo (DRUG), CM4620-IE (Injectable Emulsion) (DRUG).
Who is sponsoring clinical trial NCT04661540?
This trial is sponsored by CalciMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04661540's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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