PneumoniaPhase 2NCT04661540

A Study of Auxora in Patients With Critical COVID-19 Pneumonia

A Phase 2 study testing CM4620-IE (Injectable Emulsion) in people with Pneumonia, run by CalciMedica, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia
What is being tested?: CM4620-IE (Injectable Emulsion)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2021to 21 Dec 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
Moderate ARDS characterized by the following criteria:
Invasive mechanical ventilation with a minimum PEEP of 5 cm H2O;
PaO2/FiO2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas;
No evidence of volume overload or heart failure;
The patient is ≥18 years of age at the time of consent;

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QTcF interval ≤ 440 milliseconds;
A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug;
A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. A male patient must not donate sperm for 39 months;
The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Who cannot join

Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
ECMO;
Suspected septic shock;
The patient has a history of:
Organ or hematologic transplant;
HIV;

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Active hepatitis B or hepatitis C infection;
Current treatment with:
Chemotherapy;
Immunosuppressive medications or immunotherapy (see Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
Hemodialysis or Peritoneal Dialysis;
The patient is known to be pregnant or is nursing;
Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
Allergy to eggs or any of the excipients in study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Single-Blind Dose-Ranging Pharmacodynamic Study of Auxora for the Treatment of Patients With Critical COVID-19 Pneumonia

Read the detailed description

The primary objective of this study was to assess the pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets and chemokine release to various doses of Auxora in patients with critical COVID-19 pneumonia. Other objectives included assessment of safety and tolerability of Auxora in patients with critical COVID-19 pneumonia, as well as pharmacokinetic profile of Auxora in these patients. Efficacy was also to be examined based on all-cause mortality at day 60, number of days on mechanical ventilation after randomization, number of days in the hospital after randomization, and number of days in the ICU after randomization.

Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1 (3 Auxora, 1 Placebo). If dose escalation occurred, the next 4 patients were to be enrolled in Cohort 2. If dose escalation occurred again, the next 8 patients were to be enrolled in Cohort 3. The decision to escalate dosing was made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.

(Note: Trial terminated early after the first patient was enrolled in Cohort 3 due to lack of new Covid-19 hospitalizations.)

Conditions: Pneumonia
Being tested: CM4620-IE (Injectable Emulsion), Placebo
Keywords: COVID-19, Coronavirus, Pneumonia, Calcium Release-Activated Calcium Channel (CRAC) Inhibitors, CM4620, Auxora
Medical subject headings: Pneumonia, COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CM4620-IE (Injectable Emulsion)Drug
Also called Auxora
Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion
PlaceboDrug
Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion

Study groups in NCT04661540
Study group	Role	What they receive
Auxora	Experimental	Auxora will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours; After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours Receives: Drug: CM4620-IE (Injectable Emulsion)
Placebo	Placebo comparator	Placebo will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.
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 population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
Measured: Baseline Assessment up to 120 hours

Secondary outcomes (5)

Change From Baseline in Percent of Immune Cells in BAL Fluid
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 immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.
Measured: Baseline Assessment up to 120 hours
Number of Patients Alive at Day 60
Efficacy endpoint: All-cause Mortality at Day 60
Measured: Randomization through Day 60
Number of Days Alive and Out of the Intensive Care Unit (ICU)
Efficacy Endpoint: Days in ICU (after randomization)
Measured: From randomization until discharge from ICU, assessed up to 60 days
Number of Days Alive and Out of the Hospital
Efficacy endpoint: Days hospitalized (after randomization)
Measured: From randomization until discharge from the hospital, assessed up to 60 days
Number of Days Alive and Off Mechanical Ventilation
Efficacy endpoint: Ventilator-free days (after randomization)
Measured: From randomization until patient is extubated, assessed up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202121 Dec 2021

First posted10 Dec 2020
Study start2 Mar 2021
Primary completion21 Dec 2021
Study completion21 Dec 2021

Why it stopped: The trial was terminated early due to the limited number of new COVID-19 hospitalizations.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04661540
Sponsor's protocol ID: CM4620-205
Status last verified: Aug 2026
First submitted: 4 Dec 2020
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Casalino-Matsuda SM, Guggilla V, Gao CA, DeMeulenaere KE, Cusick L, Fenske SW, Yu Z, Lu Z, Swaminathan S, Grant RA, Schleck MJ, Prakriya M, Hebbar S, Stauderman K, Donnelly HK, Pickens CI, Morales-Nebreda L, Investigators TNSS, Wunderink RG, Misharin AV, Singer BD, Budinger GRS. The CRAC channel inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell Circuits in Viral Pneumonia. J Clin Invest. 2026 Jul 28:e209675. doi: 10.1172/JCI209675. Online ahead of print. No abstract available.
PubMed 42518274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Blind Dose-Ranging Pharmacodynamic Study of Auxora for the Treatment of Patients With Critical COVID-19 Pneumonia
ClinicalTrials.gov ID: NCT04661540
Acronym / sponsor ID: CM4620-205
Conditions: Pneumonia
Keywords: COVID-19, Coronavirus, Pneumonia, Calcium Release-Activated Calcium Channel (CRAC) Inhibitors, CM4620, Auxora
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was terminated early due to the limited number of new COVID-19 hospitalizations.
Enrolment: 10 participants (actual)
Lead sponsor: CalciMedica, Inc.Industry (pharma, biotech, devices)
Collaborators: Northwestern University
Study start: 2 Mar 2021 (actual)
Primary completion: 21 Dec 2021 (actual)
Study completion: 21 Dec 2021 (actual)
First posted: 10 Dec 2020 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

(Note: Trial terminated early after the first patient was enrolled in Cohort 3 due to lack of new Covid-19 hospitalizations.)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Auxora	Experimental	Drug: CM4620-IE (Injectable Emulsion)Auxora will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours; After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
Moderate ARDS characterized by the following criteria:
The patient is ≥18 years of age at the time of consent;
QTcF interval ≤ 440 milliseconds;
A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug;

Key exclusion criteria (14 listed)

Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
ECMO;
Suspected septic shock;
The patient has a history of:
Current treatment with:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CM4620-IE (Injectable Emulsion)Also: AuxoraAuxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion	Drug	Auxora
PlaceboMatching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion	Drug	Placebo

Primary outcome

Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.
Time frame: Baseline Assessment up to 120 hours
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 population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.

5 secondary outcomes

Change From Baseline in Percent of Immune Cells in BAL Fluid
Time frame: Baseline Assessment up to 120 hours
Number of Patients Alive at Day 60
Time frame: Randomization through Day 60
Number of Days Alive and Out of the Intensive Care Unit (ICU)
Time frame: From randomization until discharge from ICU, assessed up to 60 days
Number of Days Alive and Out of the Hospital
Time frame: From randomization until discharge from the hospital, assessed up to 60 days
Number of Days Alive and Off Mechanical Ventilation
Time frame: From randomization until patient is extubated, assessed up to 60 days

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Auxora Cohort 1	3	3
Auxora Cohort 2	0	0
Auxora Cohort 3	0	0
Placebo	1	1

Primary outcome: Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.

Time frame: Baseline Assessment up to 120 hours. Mean (Standard Deviation). Unit: Percent of total WBC population

Measure	Auxora Cohort 1 n = 3	Auxora Cohort 2 n = 3	Auxora Cohort 3 n = 1	Placebo n = 2
Value	-5.6 (31.6)	-7.2 (10.7)	27.1 (NA)	22.8 (9.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Auxora (ALL)	4 of 7 (57.1%)	7 of 7 (100%)	4 of 7
Auxora Cohort 1	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Auxora Cohort 2	3 of 3 (100%)	3 of 3 (100%)	2 of 3
Auxora Cohort 3	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Placebo	2 of 2 (100%)	2 of 2 (100%)	1 of 2

Limitations and caveats (from the sponsor): This trial was terminated early due to the limited number of new COVID-19 hospitalizations, leading to small numbers of subjects analyzed (7 randomized to Auxora and 2 randomized to placebo). Hence, no formal hypothesis testing was performed. All performed analyses were based on descriptive summaries.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 42518274Casalino-Matsuda SM, Guggilla V, Gao CA, DeMeulenaere KE, Cusick L, Fenske SW, Yu Z, Lu Z, Swaminathan S, Grant RA, Schleck MJ, Prakriya M, Hebbar S, Stauderman K, Donnelly HK, Pickens CI, Morales-Nebreda L, Investigators TNSS, Wunderink RG, Misharin AV, Singer BD, Budinger GRS. The CRAC channel inhibitor Auxora Reprograms Pathogenic Alveolar Macrophage-T Cell Circuits in Viral Pneumonia. J Clin Invest. 2026 Jul 28:e209675. doi: 10.1172/JCI209675. Online ahead of print. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CM4620-IE (Injectable Emulsion) in people with Pneumonia, run by CalciMedica, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population. (time frame: Baseline Assessment up to 120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.