PneumoniaPhase 2CARDEA-PlusNCT05171920
A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia
A Phase 2 study testing Auxora in people with Pneumonia, run by CalciMedica, Inc. at 3 sites in United States.
Trial summary
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2022to Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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, as documented by either of the following:
- PCR positive in sample collected < 72 hours prior to consent;
- PCR positive in sample collected ≥ 72 hours prior to consent, 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:
- o Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- A PaO2/FiO2 ≤200 recorded in the 24 hours before consent. The PaO2/FiO2 can be imputed from pulse oximetry;
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- Oxygen therapy being administered via HFNC or NIV
- The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
- The patient is ≥18 years of age;
- A female patient of childbearing potential must not attempt to become pregnant for 180 days, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 180 days 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 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
- 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
- Do Not Intubate order;
- PaO2/FiO2 ≤75 recorded at the time of consent. The PaO2/FiO2 can be imputed from pulse oximetry;
- Receiving IMV via endotracheal intubation or tracheostomy;
- Receiving ECMO;
- Shock defined by the use of vasopressors;
- Known history of:
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- Organ or hematologic transplant;
- HIV;
- Active hepatitis B, or hepatitis C infection;
- Current treatment with:
- Chemotherapy;
- Immunosuppressive medications or immunotherapy (see protocol (Section 5.3) for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
- Hemodialysis or Peritoneal Dialysis;
- 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;
- Known allergy to eggs or any of the excipients in study drug.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
JPS Health
Fort Worth, Texas, 76104
Regions Hospital
Saint Paul, Minnesota, 55101
Methodist Hospital
Saint Paul, Minnesota, 55426
About this study
Official title: A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus)
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora. Patients who continue to have severe hypoxemic respiratory failure at 48 hours will be randomized to receive three additional doses of Auxora or three doses of placebo. All patients will be followed for 60 days after enrollment into the study.
Read the detailed description
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora.
Patients with severe hypoxemic respiratory failure, those on HFNC with a recorded worst imputed PaO2/FiO2 ≤100 between the end of the infusion of Auxora at 24 hours and the start of the infusion of Auxora at 48 hours or are on NIV or IMV at the start of the infusion of Auxora at 48 hours, will be randomized 1:1 to receive 1.6 mg/kg (1 mL/kg) of Auxora or 1 mL/kg of Placebo at 72, 96 and 120 hours from the SFIA. Patients on IMV will be stratified between the Auxora and Placebo groups. Patients without severe hypoxemic respiratory failure, those with a recorded worst imputed PaO2/FiO2 >100 between the end of the infusion of Auxora at 24 hours and the start of the infusion of Auxora at 48 hours and are not on NIV or IMV, will not be randomized for further infusions but will remain in the study and complete all assessments through Day 60.
Patients enrolled in the study should receive dexamethasone, or equivalent dose of another corticosteroid, as standard of care. The use of remdesivir should be considered and the use of tocilizumab is encouraged.
- Conditions
- Pneumonia
- Being tested
- Auxora, 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.
AuxoraDrug
All patients will receive 2.0 mg/kg (1.25 mL/kg) of Auxora at 0 hour and 1.6 mg/kg (1 mL/kg) at both 24 hours and 48 hours from the Start of the First Infusion of Auxora (SFIA) at 0 hour over 4 hours. Patients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive extended treatment with Auxora 1.6 mg/kg (1 mL/kg) at 72, 96, and 120 hours from the SFIA
PlaceboDrug
Patients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive 1 mL/kg of Placebo at 72, 96, and 120 hours from the SFIA.
| Study group | Role | What they receive |
|---|---|---|
| Auxora | Experimental | Not described Receives: Drug: Auxora |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV or dying after 72 hours from the SFIA through day 60.
Measured: SFIA through day 60
Secondary outcomes (7)
All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora
Measured: SFIA through day 60
All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora
Measured: SFIA through day 30
Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV after 72 hours
Measured: SFIA through day 60
Number of Days in the Hospital
Measured: Hospital admission through discharge from hospital
Number of Days in the ICU
Measured: Hospital admission through discharge from the ICU
The incidence of TEAEs and SAEs
Measured: From SFIA through day 60
The intensity and relationship of TEAEs and SAEs
Measured: From SFIA 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 posted29 Dec 2021
- Study start24 Jan 2022
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: lack of sufficient numbers of critically ill patients to enroll the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 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
- NCT05171920
- Sponsor's protocol ID
- CM4620-206
- Acronym
- CARDEA-Plus
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus)
- ClinicalTrials.gov ID
- NCT05171920
- Acronym / sponsor ID
- CARDEA-Plus / CM4620-206
- Conditions
- Pneumonia
- Keywords
- COVID-19, Coronavirus, Pneumonia, Calcium release-activated calcium channel (CRAC) inhibitors, CM4620, Auxora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of sufficient numbers of critically ill patients to enroll the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CalciMedica, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora. Patients who continue to have severe hypoxemic respiratory failure at 48 hours will be randomized to receive three additional doses of Auxora or three doses of placebo. All patients will be followed for 60 days after enrollment into the study.
Detailed description
Up to 240 patients with confirmed COVID-19 pneumonia with a baseline imputed PaO2/FiO2 ≤200 receiving oxygen therapy via a high flow nasal cannula (HFNC) or non-invasive ventilation (NIV) will be enrolled at up to 40 sites. All patients will receive three doses of Auxora.
Patients with severe hypoxemic respiratory failure, those on HFNC with a recorded worst imputed PaO2/FiO2 ≤100 between the end of the infusion of Auxora at 24 hours and the start of the infusion of Auxora at 48 hours or are on NIV or IMV at the start of the infusion of Auxora at 48 hours, will be randomized 1:1 to receive 1.6 mg/kg (1 mL/kg) of Auxora or 1 mL/kg of Placebo at 72, 96 and 120 hours from the SFIA. Patients on IMV will be stratified between the Auxora and Placebo groups. Patients without severe hypoxemic respiratory failure, those with a recorded worst imputed PaO2/FiO2 >100 between the end of the infusion of Auxora at 24 hours and the start of the infusion of Auxora at 48 hours and are not on NIV or IMV, will not be randomized for further infusions but will remain in the study and complete all assessments through Day 60.
Patients enrolled in the study should receive dexamethasone, or equivalent dose of another corticosteroid, as standard of care. The use of remdesivir should be considered and the use of tocilizumab is encouraged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auxora | Experimental | Drug: Auxora |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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, as documented by either of the following:
- At least 1 of the following symptoms:
- o Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- A PaO2/FiO2 ≤200 recorded in the 24 hours before consent. The PaO2/FiO2 can be imputed from pulse oximetry;
- Oxygen therapy being administered via HFNC or NIV
Key exclusion criteria (16 listed)
- Do Not Intubate order;
- PaO2/FiO2 ≤75 recorded at the time of consent. The PaO2/FiO2 can be imputed from pulse oximetry;
- Receiving IMV via endotracheal intubation or tracheostomy;
- Receiving ECMO;
- Shock defined by the use of vasopressors;
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 |
|---|---|---|
| AuxoraAll patients will receive 2.0 mg/kg (1.25 mL/kg) of Auxora at 0 hour and 1.6 mg/kg (1 mL/kg) at both 24 hours and 48 hours from the Start of the First Infusion of Auxora (SFIA) at 0 hour over 4 hours. Patients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive extended treatment with Auxora 1.6 mg/kg (1 mL/kg) at 72, 96, and 120 hours from the SFIA | Drug | Auxora |
| PlaceboPatients with severe hypoxemic respiratory failure at 48 hours will be randomized 1:1 to receive 1 mL/kg of Placebo at 72, 96, and 120 hours from the SFIA. | Drug | Placebo |
Primary outcome
Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV or dying after 72 hours from the SFIA through day 60.
Time frame: SFIA through day 60
7 secondary outcomes
All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora
Time frame: SFIA through day 60
All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora
Time frame: SFIA through day 30
Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV after 72 hours
Time frame: SFIA through day 60
Number of Days in the Hospital
Time frame: Hospital admission through discharge from hospital
Number of Days in the ICU
Time frame: Hospital admission through discharge from the ICU
The incidence of TEAEs and SAEs
Time frame: From SFIA through day 60
The intensity and relationship of TEAEs and SAEs
Time frame: From SFIA through day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
3 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 in people with Pneumonia, run by CalciMedica, Inc. at 3 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 12 inclusion and 16 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV or dying after 72 hours from the SFIA through day 60. (time frame: SFIA through day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.