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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05171920
Other study ID # CM4620-206
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date January 24, 2022
Est. completion date July 2022

Study information

Verified date February 2022
Source CalciMedica, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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; 2. 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; 3. A PaO2/FiO2 =200 recorded in the 24 hours before consent. The PaO2/FiO2 can be imputed from pulse oximetry; 4. Oxygen therapy being administered via HFNC or NIV 5. The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs; 6. The patient is =18 years of age; 7. 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; 8. 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; 9. 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. Do Not Intubate order; 2. PaO2/FiO2 =75 recorded at the time of consent. The PaO2/FiO2 can be imputed from pulse oximetry; 3. Receiving IMV via endotracheal intubation or tracheostomy; 4. Receiving ECMO; 5. Shock defined by the use of vasopressors; 6. Known history of: - Organ or hematologic transplant; - HIV; - Active hepatitis B, or hepatitis C infection; 7. 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; 8. Known to be pregnant or is nursing; 9. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 10. Known allergy to eggs or any of the excipients in study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Auxora
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
Placebo
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.

Locations

Country Name City State
United States JPS Health Fort Worth Texas
United States Methodist Hospital Saint Paul Minnesota
United States Regions Hospital Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
CalciMedica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory: Difference in Angiopoietin 2 levels after treatment with Auxora Baseline through 192 hours
Other Exploratory: Difference in Angiopoietin 1 level after treatment with Auxora Baseline through 192 hours
Primary Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV or dying after 72 hours from the SFIA through day 60. SFIA through day 60
Secondary All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora SFIA through day 60
Secondary All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora SFIA through day 30
Secondary Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV after 72 hours SFIA through day 60
Secondary Number of Days in the Hospital Hospital admission through discharge from hospital
Secondary Number of Days in the ICU Hospital admission through discharge from the ICU
Secondary The incidence of TEAEs and SAEs From SFIA through day 60
Secondary The intensity and relationship of TEAEs and SAEs From SFIA through day 60
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