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CompletedNCT04345614Updated Mar 30, 2026Results posted

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

A Phase 2 interventional study of Auxora (Part 1) and Standard of Care (Part 1) in Pneumonia, sponsored by CalciMedica, Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Primary conditionCOVID-19Registry: PneumoniaReclassifiedWhy we changed it
Registry
Pneumonia — the first condition term the registry derived for this study.
ClinicalTrials.gg
COVID-19
Why
  1. The study's title name COVID-19, a narrower term within Pneumonia.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
314
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Pneumonia

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Keywords

  • COVID-19
  • Coronavirus
  • Pneumonia
  • Calcium release-activated calcium channel (CRAC) inhibitors
  • CM4620
  • Auxora
03

In context

COVID-19 Reclassified

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 314 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

CalciMedica, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Part 1:

Inclusion Criteria

  1. 1. The diagnosis of COVID-19 established standard RT-PCR assay;

  2. 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;

  3. 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;

  4. The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
  5. The patient is ≥18 years of age;
  6. A female patient of must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of for 39 months after the last dose of CM4620-IE;
  7. 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;
  8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide to participate, and to cooperate with all aspects of the protocol.

Exclusion Criteria:

  1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days.
  2. Do Not Intubate order;
  3. 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;
  4. 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;
  5. Noninvasive positive pressure ventilation;
  6. Invasive mechanical ventilation via endotracheal intubation or tracheostomy;
  7. ECMO;
  8. Shock defined by the use of vasopressors;
  9. Multiple organ dysfunction or failure;
  10. Positive Influenza A or B testing if tested as local standard of care;
  11. The patient has a history any of the following: Organ or hematologic transplant;; Active , or infection;
  12. Current treatment with:Chemotherapy; medications or immunotherapy at the time of consent; Hemodialysis or Peritoneal Dialysis
  13. 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;
  14. The patient is known to be pregnant or is nursing;
  15. Currently participating in another study of an drug or therapeutic medical device at the time of consent;
  16. Allergy to eggs or any of the in study drug.

Part 2:

Inclusion Criteria:

  1. 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;
  2. 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;

  3. 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;
  4. 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;
  5. The patient is ≥ 18 years of age;
  6. 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;
  7. 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;
  8. 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.

Exclusion Criteria:

  1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days.
  2. Do Not Intubate order;
  3. 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;
  4. 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;
  5. Noninvasive positive pressure ventilation;
  6. Invasive mechanical ventilation via endotracheal intubation or tracheostomy;
  7. Extracorporeal membrane oxygenation (ECMO);
  8. Shock defined by the use of vasopressors;
  9. Multiple organ dysfunction or failure;
  10. Positive Influenza A or B testing if tested as local standard of care;
  11. The patient has a history of any of the following: Organ or hematologic transplant; HIV; Active hepatitis B, or hepatitis C infection;
  12. Current treatment with:Chemotherapy;Immunosuppressive medications or immunotherapy at the time of consent; c. Hemodialysis or Peritoneal Dialysis;
  13. 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;
  14. The patient is known to be pregnant or is nursing;
  15. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
  16. Allergy to eggs or any of the excipients in study drug.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
314 participants (actual)

Study arms

  • Experimental
    Auxora (Part 1)

    Patients were randomized 1:1 to receive either Auxora or standard of care

    Drug: Auxora (Part 1)

  • Other
    Standard of Care (Part 1)

    Patients were randomized 1:1 to receive either Auxora or standard of care

    Drug: Standard of Care (Part 1)

  • Experimental
    Auxora (Part 2)

    Patients were randomized 1:1 to receive Auxora or Placebo

    Drug: Auxora (Part 2)

  • Placebo comparator
    Placebo (Part 2)

    Patients were randomized 1:1 to receive Auxora or Placebo

    Drug: Placebo (Part 2)

Interventions

  • DrugAuxora (Part 1)

    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.

    Also known as: CM4620-Injectable Emulsion (IE)

  • DrugStandard of Care (Part 1)

    Patients received standard of care

    Also known as: Placebo-Injectable Emulsion

  • DrugAuxora (Part 2)

    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.

    Also known as: CM4620-Injectable Emulsion (IE)

  • DrugPlacebo (Part 2)

    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.

    Also known as: Placebo-Injectable Emulsion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From start of first infusion of study drug to day 60

Secondary outcomes

  1. Number of Participants Who Have Died at Day 30 (Mortality)

    Time frame: Day 30

  2. Number of Participants Who Have Died at Day 60 (Mortality)

    Time frame: Day 60

  3. 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

  4. 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

  5. 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

  6. 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

    Time frame: from start of first infusion of study drug and up to day 28

  7. 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

    Time frame: from start of first infusion of study drug hrough Day 60

  8. Change in PaO2/FiO2 (Part 1)

    Measures of PaO2/FiO2 ratio

    Time frame: From start of first infusion of study drug through Day 28

  9. Number of Days in the Hospital(Part 1)

    Time to discharge alive from hospital

    Time frame: From start of first infusion of study drug through Discharge up to 28 days

  10. Number of Days in the Hospital (Part 2)

    Time frame: from admission into the hospital until discharge from the hospital up to 60 days

  11. 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

  12. Days Alive and Free of Mechanical Ventilation (Part 1)

    Time frame: From randomization through Day 28

  13. Number of Participants Considered Recovered (Part 1)

    Recovery is defined as a 6, 7, or 8 on the 8 point ordinal scale

    Time frame: From start of first infusion of study drug through Day 28

  14. CM4620-IE Plasma Concentration (Part 2)

    Concentration measured using a validated assay

    Time frame: From start of first infusion of study drug through 72 hours

  15. 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

07

Results

Posted Aug 20, 2025
Limitations and caveats
The number of patients who participated in the biomarker collection was not sufficient to provide / record meaningful results.

Participant flow

Participant flow — Overall Study
MilestoneAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Started2010143141
Part 1: low -flow oxygen therapy part 2: pao2/fio2 </= 200179130131
Completed2010143141
Not completed0000

Outcome measures

PrimaryNumber 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.

Time frame:
From start of first infusion of study drug to day 60
Reported as:
Median · Days
Number of Days From the Start of the First Infusion of Study Drug (SFISD) to Recovery
DaysAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Number of Days From the Start of the First Infusion of Study Drug (SFISD) to Recovery5 (3.0 to 10)12 (2.0 to 12)7.0 (6.0 to 9.0)10.0 (7.0 to 14.0)
SecondaryNumber of Participants Who Have Died at Day 30 (Mortality)
Time frame:
Day 30
Reported as:
Count of participants · Participants
Number of Participants Who Have Died at Day 30 (Mortality)
ParticipantsAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Number of Participants Who Have Died at Day 30 (Mortality)221023
SecondaryNumber of Participants Who Have Died at Day 60 (Mortality)
Time frame:
Day 60
Reported as:
Count of participants · Participants
Number of Participants Who Have Died at Day 60 (Mortality)
ParticipantsAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Number of Participants Who Have Died at Day 60 (Mortality)221827
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Requiring Invasive Mechanical Ventilation or Dying (Part 1)
ParticipantsAuxora (Part 1)Standard of Care (Part 1)
Number of Participants Requiring Invasive Mechanical Ventilation or Dying (Part 1)45
SecondaryProportion 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
Reported as:
Number · Proportion of Participants
Proportion of Patients Requiring Invasive Mechanical Ventilation or Dying (Part 2)
Proportion of ParticipantsAuxora (Part 2)Placebo (Part 2)
Proportion of Patients Requiring Invasive Mechanical Ventilation or Dying (Part 2).23 (0.17 to 0.31).31 (0.24 to 0.39)
SecondaryProportion of Patients Requiring Invasive Mechanical Ventilation (Part 2)
Time frame:
from start of first infusion of study drug and up to day Day 60
Reported as:
Number · Proportion of participants
Proportion of Patients Requiring Invasive Mechanical Ventilation (Part 2)
Proportion of participantsAuxora (Part 2)Placebo (Part 2)
Proportion of Patients Requiring Invasive Mechanical Ventilation (Part 2)0.19 (0.13 to 0.28)0.28 (0.21 to 0.37)
SecondaryImprovement 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

Time frame:
from start of first infusion of study drug and up to day 28
Reported as:
Mean · score on a scale
Improvement in 8-point Ordinal Scale (Part 1)
score on a scaleAuxora (Part 1)Standard of Care (Part 1)
Improvement in 8-point Ordinal Scale (Part 1)6.3 ± 2.394.6 ± 2.92
SecondaryDifferences 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

Time frame:
from start of first infusion of study drug hrough Day 60
Reported as:
Count of participants · Participants
Differences in Outcomes as Measured by an 8-point Ordinal Scale (Part 2)
ParticipantsAuxora BaselinePlacebo BaselineAuxora Day 12Placebo Day 12Auxora Day 30Placebo Day 30Auxora Day 60Placebo Day 60
1005810231827
200112311835
3818217165300
44949672200
500000000
600001225
700383924333233
800453671586959
SecondaryChange in PaO2/FiO2 (Part 1)

Measures of PaO2/FiO2 ratio

Time frame:
From start of first infusion of study drug through Day 28
Reported as:
Mean · ratio of the arterial partial pressure o
Change in PaO2/FiO2 (Part 1)
ratio of the arterial partial pressure oAuxora (Part 1)Standard of Care (Part 1)
Change in PaO2/FiO2 (Part 1)66.94 ± 152.673153.31 ± 153.258
SecondaryNumber of Days in the Hospital(Part 1)

Time to discharge alive from hospital

Time frame:
From start of first infusion of study drug through Discharge up to 28 days
Reported as:
Median · Days
Number of Days in the Hospital(Part 1)
DaysAuxora (Part 1)Standard of Care (Part 1)
Number of Days in the Hospital(Part 1)5 (3 to 10)12 (2 to NA)
SecondaryNumber of Days in the Hospital (Part 2)
Time frame:
from admission into the hospital until discharge from the hospital up to 60 days
Reported as:
Least squares mean · Days
Number of Days in the Hospital (Part 2)
DaysAuxoraPlacebo
Number of Days in the Hospital (Part 2)13.65 (11.92 to 15.38)15.29 (13.57 to 17.01)
SecondaryNumber of Days in the Intensive Care Unit (ICU) (Part 2)
Time frame:
from admission into ICU until discharge from ICU up to 60 days
Reported as:
Least squares mean · Days
Number of Days in the Intensive Care Unit (ICU) (Part 2)
DaysAuxoraPlacebo
Number of Days in the Intensive Care Unit (ICU) (Part 2)6.88 (4.92 to 8.85)8.36 (6.40 to 10.32)
SecondaryDays Alive and Free of Mechanical Ventilation (Part 1)
Time frame:
From randomization through Day 28
Reported as:
Mean · Days
Days Alive and Free of Mechanical Ventilation (Part 1)
DaysAuxora (Part 1)Standard of Care (Part 1)
Days Alive and Free of Mechanical Ventilation (Part 1)22.9 ± 10.312.9 ± 14.3
SecondaryNumber of Participants Considered Recovered (Part 1)

Recovery is defined as a 6, 7, or 8 on the 8 point ordinal scale

Time frame:
From start of first infusion of study drug through Day 28
Reported as:
Count of participants · Participants
Number of Participants Considered Recovered (Part 1)
ParticipantsAuxora (Part 1)Standard of Care (Part 1)
Number of Participants Considered Recovered (Part 1)144
SecondaryCM4620-IE Plasma Concentration (Part 2)

Concentration measured using a validated assay

Time frame:
From start of first infusion of study drug through 72 hours
Reported as:
Geometric mean · ng/mL
CM4620-IE Plasma Concentration (Part 2)
ng/mLAuxoraPlacebo
CM4620-IE Plasma Concentration (Part 2)165.2 ± 91.9—
SecondaryPercentage 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
Reported as:
Number · percentage of patients
Percentage of Patients With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
percentage of patientsAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Patients with at least 1 TEAE75.080.064.561.4
Mild TEAE20.020.029.817.9
Moderate TEAE25.010.010.68.6
Severe TEAE25.010.024.135
Patients with at least one treatment related TEAE15.00.025.512.9

Adverse events

Collected over Adverse event (AE) data were collected from randomization through Day 60. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Auxora (Part 1)2/20 (10%)6/20 (30%)15/20 (75%)
Standard of Care (Part 1)2/10 (20%)5/10 (50%)8/10 (80%)
Auxora (Part 2)18/141 (12.8%)34/141 (24.1%)69/141 (48.9%)
Placebo (Part 2)27/140 (19.3%)49/140 (35%)68/140 (48.6%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Septic shockInfections and infestations3/202/102/1418/140
Respiratory failureRespiratory, thoracic and mediastinal disorders3/202/1022/14126/140
Bacterial PneumoniaInfections and infestations2/200/101/1410/140
PneumoniaInfections and infestations0/201/106/1417/140
SepsisInfections and infestations0/201/100/1411/140
ARDSRespiratory, thoracic and mediastinal disorders2/201/107/14111/140
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders0/201/103/1412/140
Respiratory DistressRespiratory, thoracic and mediastinal disorders0/201/100/1410/140
Deep Vein ThrombosisVascular disorders0/201/102/1413/140
Atrial FibrillationCardiac disorders1/200/102/1410/140
Most frequent other events
Showing 10 of 21
Most frequent other events
EventAuxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)
Blood triglycerides increasedMetabolism and nutrition disorders1/202/1016/1415/140
Gastrointestinal HaemorrhageGastrointestinal disorders0/202/100/1412/140
HyperglycemiaMetabolism and nutrition disorders3/200/1011/14111/140
HypoglycaemiaMetabolism and nutrition disorders3/200/101/1413/140
DVTVascular disorders0/201/105/1414/140
HyperkalemiaMetabolism and nutrition disorders0/201/104/1416/140
AnemiaBlood and lymphatic system disorders2/201/102/1418/140
Blood Alkaline Phosphatase IncreasedInvestigations2/200/100/1410/140
Blood Creatine Phosphokinase IncreasedInvestigations2/201/100/1410/140
HypotensionVascular disorders2/201/102/1411/140

Baseline characteristics

Age, Continuous
Age, Continuous(years)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Mean59.3 ± 12.4761.0 ± 13.3259.4 ± 12.160.4 ± 12.359.9 ± 12.2
Sex: Female, Male
Sex: Female, Male(Participants)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Female104463999
Male758492188
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Hispanic or Latino214558106
Not Hispanic or Latino1468272174
Unknown or Not Reported12317
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
American Indian or Alaska Native00000
Asian019515
Native Hawaiian or Other Pacific Islander00011
Black or African American73191241
White858598196
More than one race20161533
Unknown or Not Reported00101
Region of Enrollment
Region of Enrollment(participants)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
United States179130131287
65+years of age
65+years of age(Participants)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Count of participants444547100
Body Mass Index
Body Mass Index(kg/m^2)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Mean34.4 ± 13.533.1 ± 8.5832.8 ± 8.832.0 ± 7.032.4 ± 8.0
Time from symptom onset
Time from symptom onset(Days)Auxora (Part 1)Standard of Care (Part 1)Auxora (Part 2)Placebo (Part 2)Total
Mean11.1 ± 7.136.9 ± 2.5912.2 ± 5.812.0 ± 5.912.1 ± 5.8

10 further baseline measures are reported on the registry.

08

Study locations

17 sites
  • Long Beach Memorial
    Long Beach, California 90806, United States
  • University of Southern California / LA County
    Los Angeles, California 90033, United States
  • Sharp Memorial San Diego
    San Diego, California 92123, United States
  • National Jewish Health / St. Joseph's Hospital
    Denver, Colorado 80220, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Baton Rouge General
    Baton Rouge, Louisiana 70809, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Sinai Grace
    Detroit, Michigan 48235, United States
  • Methodist Hospital
    Saint Louis Park, Minnesota 55426, United States
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
  • Texas Tech University Medical Center
    El Paso, Texas 79905, United States
  • John Peter Smith Hospital
    Fort Worth, Texas 76104, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Aurora Baycare
    Green Bay, Wisconsin 54311, United States
09

References and documents

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 35395943 ↗
  • Miller 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04345614
Lead sponsor
CalciMedica, Inc.
Responsible party
Sponsor
First posted
Apr 14, 2020
Start date
Apr 8, 2020
Primary completion
Jun 28, 2021
Completion
Jul 30, 2021
Results posted
Aug 20, 2025
Last update
Mar 30, 2026

Study contacts

Sudarshan Hebbar, MD
study director · CalciMedica, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Zegocractin

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