PneumoniaPhase 2NCT04345614
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
A Phase 2 study testing Auxora (Part 1) and Auxora (Part 2) in people with Pneumonia, run by CalciMedica, Inc. at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Auxora (Part 1) and Auxora (Part 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 17 sitesUnited States
- Study dates
- 8 Apr 2020to 30 Jul 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
- 1. The diagnosis of COVID-19 established standard RT-PCR assay;
- At least 1 of the following symptoms:
- Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- At least 1 of the following clinical signs:
- Respiratory rate ≥30, heart rate ≥125, SpO2 <93% on room air or requires >2L oxygen by nasal cannula to maintain SpO2 ≥93%, or PaO2/FiO2 <300, estimated from pulse oximetry or determined by arterial blood gas;
- The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
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- The patient is ≥18 years of age;
- 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 CM4620-IE;
- 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 CM4620-IE. 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.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either of the following:
- PCR positive in sample collected < 72 hours prior to randomization;
- PCR positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing SARS-CoV-2 infection;
- At least 1 of the following symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- At least 1 of the following signs at Screening or noted in the 24 hours before Screening:
- PaO2/FiO2 ≤200 when receiving supplemental oxygen. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- If SpO2 ≥97%, must be receiving 10L or more of supplemental oxygen;
- The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest X-ray or computerized tomography scan of the lungs;
- The patient is ≥ 18 years of age;
- 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 CM4620-IE;
- 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 CM4620-IE. 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.
- Do Not Intubate order;
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing;
- PaO2/FiO2 ≤75 at the time of Screening. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- Noninvasive positive pressure ventilation;
- Invasive mechanical ventilation via endotracheal intubation or tracheostomy;
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- ECMO;
- Shock defined by the use of vasopressors;
- Multiple organ dysfunction or failure;
- Positive Influenza A or B testing if tested as local standard of care;
- The patient has a history any of the following: Organ or hematologic transplant;HIV; Active hepatitis B, or hepatitis C infection;
- Current treatment with:Chemotherapy; Immunosuppressive medications or immunotherapy at the time of consent; Hemodialysis or Peritoneal Dialysis
- Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (> 1) VTE;
- 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.
- Part 2:
- Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
- Do Not Intubate order;
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing;
- PaO2/FiO2 ≤75 at the time of Screening. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- Noninvasive positive pressure ventilation;
- Invasive mechanical ventilation via endotracheal intubation or tracheostomy;
- Extracorporeal membrane oxygenation (ECMO);
- Shock defined by the use of vasopressors;
- Multiple organ dysfunction or failure;
- Positive Influenza A or B testing if tested as local standard of care;
- The patient has a history of any of the following: Organ or hematologic transplant; HIV; Active hepatitis B, or hepatitis C infection;
- Current treatment with:Chemotherapy;Immunosuppressive medications or immunotherapy at the time of consent; c. Hemodialysis or Peritoneal Dialysis;
- Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (> 1) VTE;
- 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Baton Rouge General
Baton Rouge, Louisiana, 70809
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
National Jewish Health / St. Joseph's Hospital
Denver, Colorado, 80220
Henry Ford Hospital
Detroit, Michigan, 48202
Sinai Grace
Detroit, Michigan, 48235
Texas Tech University Medical Center
El Paso, Texas, 79905
John Peter Smith Hospital
Fort Worth, Texas, 76104
Aurora Baycare
Green Bay, Wisconsin, 54311
Houston Methodist Hospital
Houston, Texas, 77030
Long Beach Memorial
Long Beach, California, 90806
University of Southern California / LA County
Los Angeles, California, 90033
Maine Medical Center
Portland, Maine, 04102
Virginia Commonwealth University
Richmond, Virginia, 23298
Methodist Hospital
Saint Louis Park, Minnesota, 55426
Regions Hospital
Saint Paul, Minnesota, 55101
Sharp Memorial San Diego
San Diego, California, 92123
About this study
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)
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
- Pneumonia
- Being tested
- Auxora (Part 1), Standard of Care (Part 1), Auxora (Part 2), Placebo (Part 2)
- 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.
Auxora (Part 1)Drug
Also called CM4620-Injectable Emulsion (IE)
Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours.
Standard of Care (Part 1)Drug
Also called Placebo-Injectable Emulsion
Patients received standard of care
Auxora (Part 2)Drug
Also called CM4620-Injectable Emulsion (IE)
Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours.
Placebo (Part 2)Drug
Also called Placebo-Injectable Emulsion
Placebo will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Placebo will be administered intravenously (IV) over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Auxora (Part 1) | Experimental | Patients were randomized 1:1 to receive either Auxora or standard of care Receives: Drug: Auxora (Part 1) |
| Standard of Care (Part 1) | Other | Patients were randomized 1:1 to receive either Auxora or standard of care Receives: Drug: Standard of Care (Part 1) |
| Auxora (Part 2) | Experimental | Patients were randomized 1:1 to receive Auxora or Placebo Receives: Drug: Auxora (Part 2) |
| Placebo (Part 2) | Placebo comparator | Patients were randomized 1:1 to receive Auxora or Placebo Receives: Drug: Placebo (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days From the Start of the First Infusion of Study Drug (SFISD) to Recovery
Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.
Measured: From start of first infusion of study drug to day 60
Secondary outcomes (15)
Number of Participants Who Have Died at Day 30 (Mortality)
Measured: Day 30
Number of Participants Who Have Died at Day 60 (Mortality)
Measured: Day 60
Number of Participants Requiring Invasive Mechanical Ventilation or Dying (Part 1)
Measured: From start of first infusion of study drug and up to Day 28
Proportion of Patients Requiring Invasive Mechanical Ventilation or Dying (Part 2)
Measured: from start of first infusion of study drug and up to day day 60
Proportion of Patients Requiring Invasive Mechanical Ventilation (Part 2)
Measured: from start of first infusion of study drug and up to day Day 60
Improvement in 8-point Ordinal Scale (Part 1)
The ordinal scale is an assessment of the clinical status in a given day. The scale is as follows: 1. Death 2. Hospitalized, requiring invasive mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow supplemental oxygen 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care 6. Hospitalized, not requiring supplemental oxygen or ongoing medical care 7. discharged, requiring supplemental oxygen 8. Discharged, not requiring supplemental oxygen
Measured: from start of first infusion of study drug and up to day 28
Differences in Outcomes as Measured by an 8-point Ordinal Scale (Part 2)
The ordinal scale is an assessment of the clinical status in a given day. The scale is as follows: 1. Death 2. Hospitalized, requiring invasive mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow supplemental oxygen 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care 6. Hospitalized, not requiring supplemental oxygen or ongoing medical care 7. discharged, requiring supplemental oxygen 8. Discharged, not requiring supplemental oxygen
Measured: from start of first infusion of study drug hrough Day 60
Change in PaO2/FiO2 (Part 1)
Measures of PaO2/FiO2 ratio
Measured: From start of first infusion of study drug through Day 28
Number of Days in the Hospital(Part 1)
Time to discharge alive from hospital
Measured: From start of first infusion of study drug through Discharge up to 28 days
Number of Days in the Hospital (Part 2)
Measured: from admission into the hospital until discharge from the hospital up to 60 days
Number of Days in the Intensive Care Unit (ICU) (Part 2)
Measured: from admission into ICU until discharge from ICU up to 60 days
Days Alive and Free of Mechanical Ventilation (Part 1)
Measured: From randomization through Day 28
Number of Participants Considered Recovered (Part 1)
Recovery is defined as a 6, 7, or 8 on the 8 point ordinal scale
Measured: From start of first infusion of study drug through Day 28
CM4620-IE Plasma Concentration (Part 2)
Concentration measured using a validated assay
Measured: From start of first infusion of study drug through 72 hours
Percentage of Patients With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Measured: From start of first infusion of study drugand through day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start8 Apr 2020
- Primary completion28 Jun 2021
- Study completion30 Jul 2021
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 (2)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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- CalciMedica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudarshan Hebbar, MD, Study director, CalciMedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345614
- Sponsor's protocol ID
- CM4620-204
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2020
- Last updated
- 30 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35395943Miller 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.
PubMed 32795330
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04345614
- Acronym / sponsor ID
- CM4620-204
- Conditions
- Pneumonia
- Keywords
- COVID-19, Coronavirus, Pneumonia, Calcium release-activated calcium channel (CRAC) inhibitors, CM4620, Auxora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- CalciMedica, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Auxora (Part 1) | Experimental | Drug: Auxora (Part 1)Patients were randomized 1:1 to receive either Auxora or standard of care |
| Standard of Care (Part 1) | Other | Drug: Standard of Care (Part 1)Patients were randomized 1:1 to receive either Auxora or standard of care |
| Auxora (Part 2) | Experimental | Drug: Auxora (Part 2)Patients were randomized 1:1 to receive Auxora or Placebo |
| Placebo (Part 2) | Placebo comparator | Drug: Placebo (Part 2)Patients were randomized 1:1 to receive Auxora or Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 1. The diagnosis of COVID-19 established standard RT-PCR assay;
- At least 1 of the following symptoms:
- Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- At least 1 of the following clinical signs:
- Respiratory rate ≥30, heart rate ≥125, SpO2 <93% on room air or requires >2L oxygen by nasal cannula to maintain SpO2 ≥93%, or PaO2/FiO2 <300, estimated from pulse oximetry or determined by arterial blood gas;
Key exclusion criteria (33 listed)
- Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
- Do Not Intubate order;
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing;
- PaO2/FiO2 ≤75 at the time of Screening. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- Noninvasive positive pressure ventilation;
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 |
|---|---|---|
| Auxora (Part 1)Also: CM4620-Injectable Emulsion (IE)Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. | Drug | Auxora (Part 1) |
| Standard of Care (Part 1)Also: Placebo-Injectable EmulsionPatients received standard of care | Drug | Standard of Care (Part 1) |
| Auxora (Part 2)Also: CM4620-Injectable Emulsion (IE)Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours. | Drug | Auxora (Part 2) |
| Placebo (Part 2)Also: Placebo-Injectable EmulsionPlacebo will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Placebo will be administered intravenously (IV) over 4 hours. | Drug | Placebo (Part 2) |
Primary outcome
Number of Days From the Start of the First Infusion of Study Drug (SFISD) to Recovery
Time frame: From start of first infusion of study drug to day 60
Defined as the number of days hospitalized but not requiring supplemental oxygen or ongoing medical care, or; discharged and requiring supplemental oxygen, or; discharged, not requiring supplemental oxygen.
15 secondary outcomes
Number of Participants Who Have Died at Day 30 (Mortality)
Time frame: Day 30
Number of Participants Who Have Died at Day 60 (Mortality)
Time frame: Day 60
Number of Participants Requiring Invasive Mechanical Ventilation or Dying (Part 1)
Time frame: From start of first infusion of study drug and up to Day 28
Proportion of Patients Requiring Invasive Mechanical Ventilation or Dying (Part 2)
Time frame: from start of first infusion of study drug and up to day day 60
Proportion of Patients Requiring Invasive Mechanical Ventilation (Part 2)
Time frame: from start of first infusion of study drug and up to day Day 60
Improvement in 8-point Ordinal Scale (Part 1)
Time frame: from start of first infusion of study drug and up to day 28
Differences in Outcomes as Measured by an 8-point Ordinal Scale (Part 2)
Time frame: from start of first infusion of study drug hrough Day 60
Change in PaO2/FiO2 (Part 1)
Time frame: From start of first infusion of study drug through Day 28
Number of Days in the Hospital(Part 1)
Time frame: From start of first infusion of study drug through Discharge up to 28 days
Number of Days in the Hospital (Part 2)
Time frame: from admission into the hospital until discharge from the hospital up to 60 days
Number of Days in the Intensive Care Unit (ICU) (Part 2)
Time frame: from admission into ICU until discharge from ICU up to 60 days
Days Alive and Free of Mechanical Ventilation (Part 1)
Time frame: From randomization through Day 28
Number of Participants Considered Recovered (Part 1)
Time frame: From start of first infusion of study drug through Day 28
CM4620-IE Plasma Concentration (Part 2)
Time frame: From start of first infusion of study drug through 72 hours
Percentage of Patients With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: From start of first infusion of study drugand through day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35395943Bruen 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.
- Derived from this study: PubMed 32795330Miller 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.
- Auxora vs. SOC for the treatment of severe COVID-19 pneumonia: a Phase 2 study (Part 1, open label)Link provided by the sponsor.
- Auxora vs. placebo for the treatment of severe COVID-19 pneumonia: a Phase 2 study (Part 2, double-blinded)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sudarshan Hebbar, MD study director
CalciMedica, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auxora (Part 1) and Auxora (Part 2) in people with Pneumonia, run by CalciMedica, Inc. at 17 sites 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 22 inclusion and 33 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: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 20 Aug 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?
Number of Days From the Start of the First Infusion of Study Drug (SFISD) to Recovery (time frame: From start of first infusion of study drug to day 60). 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 NCT04345614, which also lists 2 linked publications.
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 30 Mar 2026.