A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia

NCT05171920 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CM4620-206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora

  SFIA through day 60

• All-Cause Mortality in randomized patients receiving 6 versus 3 doses of Auxora

  SFIA through day 30

• Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV after 72 hours

  SFIA through day 60

• Number of Days in the Hospital

  Hospital admission through discharge from hospital

• Number of Days in the ICU

  Hospital admission through discharge from the ICU

Other Outcomes (2)

• Exploratory: Difference in Angiopoietin 2 levels after treatment with Auxora

  Baseline through 192 hours

• Exploratory: Difference in Angiopoietin 1 level after treatment with Auxora

  Baseline through 192 hours

Study Arms (2)

Auxora

EXPERIMENTAL

Drug: Auxora

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Auxora DRUG

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

Auxora

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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:
• 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;

Sponsors & Collaborators

• CalciMedica, Inc.: lead

Study Sites (3)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Methodist Hospital

Saint Paul, Minnesota, 55426, United States

Location

JPS Health

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pneumonia; COVID-19; Coronavirus Infections

Interventions

zegocractin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Sudarshan Hebbar, MD

  CalciMedica, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: December 29, 2021
• Study Start: January 24, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)