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A Study of CM4620-Injectable Emulsion (IE) in Patients With Severe COVID-19 Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345614
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
CalciMedica, Inc.

Brief Summary:
This open-label randomized controlled study will evaluate safety, efficacy, and the pharmacokinetic profile of CM4620-IE in patients with severe COVID-19 pneumonia. Forty patients on low flow oxygen and forty patients on high flow oxygen will receive 2.0 mg/kg of CM4620-IE by continuous IV infusion on Day 1, followed by 1.6 mg/kg for days 2 and 3. Another 20 patients of each will receive local standard of care only. The infusion of CM4620-IE will start within 8 hours from the time the patient or LAR provides informed consent.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: CM4620-Injectable Emulsion Phase 2

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Study Type : Interventional
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Open-Label Study of CM4620 Injectable Emulsion in Patients With Severe COVID-19 Pneumonia
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: CM4620-IE Low Flow Oxygen Therapy
Forty patients on low flow oxygen therapy will be randomized 2:1 to receive CM4620-IE versus local standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.0 mg/kg on Day 1 and 1.6 mg/kg on Days 2 and 3.
Drug: CM4620-Injectable Emulsion
CM4620-IE 2.0 mg/kg on Day 1 and then 1.6 mg/kg on Days 2 and 3. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
Other Name: CM4620-IE

No Intervention: Local Standard of Care Low Flow Oxygen Therapy
Twenty patients on low flow oxygen therapy will be randomized 1:2 to receive local standard of care vs CM4620-IE.
Experimental: CM4620-IE High Flow Oxygen Therapy
Forty patients on high flow oxygen therapy will be randomized 2:1 to receive CM4620-IE versus local standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.0 mg/kg on Day 1 and 1.6 mg/kg on Days 2 and 3.
Drug: CM4620-Injectable Emulsion
CM4620-IE 2.0 mg/kg on Day 1 and then 1.6 mg/kg on Days 2 and 3. All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
Other Name: CM4620-IE

No Intervention: Local Standard of Care High Flow Oxygen Therapy
Twenty patients on high flow oxygen therapy will be randomized 1:2 to receive local standard of care vs CM4620-IE.



Primary Outcome Measures :
  1. Improvement on a 7-point Ordinal Scale [ Time Frame: Upon enrollment into the study through hospital discharge, up to day 28 ]
    The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol study drug administration) 7. Not hospitalized

  2. Incidence of treatment-emergent adverse events (TEAE) (safety and tolerability) [ Time Frame: from enrollment and up to 60 days ]
    Defined as the number of participants who experience TEAEs with investigator-specified relationship to CM4620-IE and assessment of severity.


Secondary Outcome Measures :
  1. Change in estimated PaO2/FiO2 [ Time Frame: from enrollment and up to day 28 ]
    Defined as the change in the ratio of arterial oxygen partial pressure to fractional inspired oxygen

  2. Number of days alive and free of mechanical ventilation [ Time Frame: from enrollment and up to day 60 ]
    Defined as the number of days that a participant is both alive and free of mechanical ventilation

  3. Time to discharge alive from hospital [ Time Frame: From day 1 of hospital admission to hospital discharge, up to day 28 ]
    Defined as the number of days from hospital admission to discharge alive from the hospital

  4. Number of patients alive on day 30 and day 60 [ Time Frame: Day 30 and day 60 ]
  5. Change in interleukin (IL)-6 level [ Time Frame: from enrollment until day 10 ]
    Measurement of IL-6 levels in patient blood

  6. Change in IL-17 level [ Time Frame: from enrollment until day 10 ]
    Measurement of IL-17 levels in patient blood

  7. Change in tumor necrosis factor-alpha level [ Time Frame: from enrollment until day 10 ]
    Measurement of tumor necrosis factor-alpha in patient blood

  8. Change in cytokine levels [ Time Frame: from enrollment until day 10 ]
    Measurement of cytokines in patient blood

  9. CM4620-IE serum concentration [ Time Frame: enrollment through 72 hours ]
    Concentration measured using a validated assay

  10. Procalcitonin levels [ Time Frame: from enrollment through day 28 ]
    Measurement of procalcitonin in patient blood

  11. Normalization of oxygen saturation [ Time Frame: from enrollment until day 28 ]
    Defined as the time to peripheral capillary oxygen saturation (SpO2) >94% sustained for at least 24 hours

  12. Time to first normalization of oxygen saturation [ Time Frame: from enrollment until day 28 ]
    Defined as the time to peripheral capillary oxygen saturation (SpO2) >94%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The diagnosis of COVID-19 established standard reverse transcription polymerase chain reaction (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, arterial oxygen saturation (SaO2) <93% on room air or requires >2 liters oxygen by nasal cannula to maintain SaO2 ≥93%, or arterial oxygen partial pressure/inspired oxygen fraction (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 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. Endotracheal intubation;
  5. Noninvasive positive pressure ventilation;
  6. Extracorporeal membrane oxygenation (ECMO);
  7. Shock defined by systolic blood pressure (SBP) <90 or diastolic blood pressure (DBP) <60 or use of vasopressors;
  8. Multiple organ failure;
  9. Positive Influenza A or B testing;
  10. Pathogens detected by a respiratory panel tested as local standard of care;
  11. The patient has a history of:

    1. Organ or hematologic transplant;
    2. HIV;
    3. Active hepatitis B, or hepatitis C infection;
  12. Current treatment with:

    1. Chemotherapy;
    2. Glucocorticoids at the time of consent;
    3. Immunosuppressive medications or immunotherapy (see Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
    4. Hemodialysis or Peritoneal Dialysis;
  13. The patient is known to be pregnant or is nursing;
  14. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
  15. Allergy to eggs or known hypersensitivity to any components of CM4620-IE.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345614


Contacts
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Contact: Sudarshan Hebbar, MD 816-838-7105 sudarshan@calcimedica.com
Contact: Ken Stauderman, PhD 858-353-2726 ken@calcimedica.com

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Kathleen Wilson, RN    313-916-9551    kwilso10@hfhs.org   
Principal Investigator: Joseph Miller, MD         
United States, Minnesota
Methodist Hospital Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Marissa Peterson    651-254-5321    marissa.k.peterson@healthpartners.com   
Principal Investigator: Michael Schnaus, MD         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Marissa K. Peterson    651-254-5321    marissa.k.peterson@healthpartners.com   
Principal Investigator: Charles Bruen, MD         
Sponsors and Collaborators
CalciMedica, Inc.
Investigators
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Study Director: Sudarshan Hebbar, MD CalciMedica, Inc.
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Responsible Party: CalciMedica, Inc.
ClinicalTrials.gov Identifier: NCT04345614    
Other Study ID Numbers: CM4620-204
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CalciMedica, Inc.:
COVID-19
Coronavirus
Pneumonia
Calcium release-activated calcium channel (CRAC) inhibitors
CM4620
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections