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IRIS-7-B: A Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients

Sponsor
Revimmune (Industry)
Overall Status
Completed
CT.gov ID
NCT02640807
Collaborator
Vanderbilt University School of Medicine (Other), Washington University School of Medicine (Other)
27
Enrollment
1
Location
3
Arms
31.8
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis patients).

A parallel study will be performed in France to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Sepsis is the leading cause of death in critically ill patients in most intensive care units in Europe and the US. Recently, evidence has accumulated that sepsis progresses from a state of hyper-inflammation to a state of immunosuppression. This immunosuppressive phase is characterized by increased incidence of secondary infections often with relatively avirulent opportunistic type pathogens. Currently, new therapeutic approaches to sepsis are occurring using immuno-adjuvants that boost host immunity. One of the most promising agents Interleukin-7 is an essential, non-redundant, pluripotent cytokine produced mainly by bone marrow and thymic stromal cells that is required for T-cell survival.In addition to its anti-apoptotic properties, IL-7 induces potent proliferation of naïve and memory T-cells potentially supporting replenishment of the peripheral T-cell pool which is severely depleted during sepsis. These effects were confirmed in clinical trials at the National Cancer Institute and in HIV+ patients.

This clinical study will test the ability of IL-7 to restore the absolute lymphocyte counts in septic patients who have markedly reduced levels of circulating lymphocytes. An effect already confirmed in preclinical models of sepsis.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Two Dosing Frequencies of Recombinant Interleukin-7 (CYT107) Treatment to Restore Absolute Lymphocyte Counts in Sepsis Patients.
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Aug 27, 2018
Actual Study Completion Date :
Aug 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: CYT107 high frequency

Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks

Drug: Interleukin-7
IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000
Other Names:
  • CYT107

    		•
    Experimental: CYT107 low frequency

    Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks

    Drug: Interleukin-7
    IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000
    Other Names:
  • CYT107

    • Drug: Placebo
    IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Other Names:
  • NaCl 0.9%

    		•
    Placebo Comparator: Control

    Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks

    Drug: Placebo
    IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Other Names:
  • NaCl 0.9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immune Reconstitution of Lymphocytopenic Sepsis Patients [Day 0 to 42]

      Number of patients showing an increase of Absolute Lymphocyte Count >50% from baseline at Day 42. Kinetic of immune restoration through weekly measures of Absolute Lymphocyte Counts

    Secondary Outcome Measures

    1. CYT107 Effect on Absolute Lymphocyte Count [Day 42]

      Number of Patients with Absolute Lymphocyte Count > 1.2 at Day 42

    2. CYT107 Immunogenicity [Day 60]

      number of patients with binding or neutralizing antibodies against CYT107 at Day 60

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients of age ≥ 18 yrs and older but < 80 yrs

    2. Patients with persistent suspected sepsis at 48-120 hrs after admission

    3. Two or more criteria for the systemic inflammatory response syndrome (SIRS) (see reference #19 for SIRS criteria) and a clinically or microbiologically suspected infection.

    4. At least one organ failure as defined by a SOFA (Sepsis-related organ failure assessment) score of ≥2 at any time point during the 48-120 hrs after admission to the ICU

    5. Requirement of vasopressor treatment as follows: i) epinephrine or norepinephrine at ≥ 0.05 µg/kg/min ideal body weight; ii) vasopressin, or iii) dopamine at ≥ 4-5 μg/kg/min ideal body weight, continuously for 4 hrs or more, provided that at least 20 ml/kg of ideal body weight of crystalloid or an equivalent volume of colloid was administered during the 24-hour interval surrounding the start of vasopressor treatment, to maintain systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥ 60 mmHg at any time point during their sepsis course preceding enrollment into the IL-7 study.

    6. Lymphopenia with an absolute lymphocyte count ≤ 900 cells/mm3 at either the day of consent or the day prior to consent during their ICU stay.

    7. Predicted length of stay in the ICU of up to two weeks after starting drug therapy treatment in the trial (ICU may also include a close medical ward on the same study site where the patient will remain under medical control of the Investigator).

    8. Ability to obtain a signed informed consent from patient or LAR (Legally Authorized Representative) consent.

    Exclusion Criteria:

    1. Cancer with current chemotherapy or radiotherapy and/or .receipt of chemotherapy or radiotherapy within the last 6 weeks

    2. Cardiopulmonary resuscitation within the previous 4 weeks without objective evidence of full neurologic recovery) or patients who have minimal chance of survival and are not expected to live > 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility

    3. Patients with a history of or who currently have evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.

    4. Patients who have received solid organ transplant or bone marrow transplant

    5. Patients with active or a history of acute or chronic lymphocytic leukemia

    6. AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry

    7. History of splenectomy

    8. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia

    9. Pregnant or lactating women

    10. Participation in another investigational interventional study within the last 6 months prior to study entry, with the exception of studies aimed at testing sedation products belonging to standard of care such as Propofol, Dexmedetomidine, Midazolam.

    11. Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for rheumatoid arthritis, inflammatory bowel disease or any other reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day

    12. Patients receiving concurrent immunotherapy or biologic agents including: growth factors, cytokines and interleukins, (other than the study medication); for example IL-2,growth factors, interferons, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy

    13. Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37212-1050

    Sponsors and Collaborators

    • Revimmune
    • Vanderbilt University School of Medicine
    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Edward SHERWOOD, MD, PhD, Vanderbilt University Medical Center
    • Study Director: Richard HOTCHKISS, MD, PhD, Washington University School of Medicine

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Revimmune
    ClinicalTrials.gov Identifier:
    NCT02640807
    Other Study ID Numbers:
    • CLI-107-15
    First Posted:
    Dec 29, 2015
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by Revimmune
    sepsis lymphocytopenia IL-7
    immune reconstitution
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Period Title: Overall Study
    STARTED 9 8 10
    COMPLETED 9 8 10
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control Total
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Total of all reporting groups
    Overall Participants 9 8 10 27
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    62
    68
    56
    62
    Sex: Female, Male (Count of Participants)
    Female
    2
    22.2%
    2
    25%
    2
    20%
    6
    22.2%
    Male
    7
    77.8%
    6
    75%
    8
    80%
    21
    77.8%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    4
    44.4%
    3
    37.5%
    4
    40%
    11
    40.7%
    France
    5
    55.6%
    5
    62.5%
    6
    60%
    16
    59.3%
    SOFA Score (units on a scale) [Mean (Full Range) ]
    Mean (Full Range) [units on a scale]
    6
    5
    8
    6

    Outcome Measures

    1. Primary Outcome
    Title Immune Reconstitution of Lymphocytopenic Sepsis Patients
    Description Number of patients showing an increase of Absolute Lymphocyte Count >50% from baseline at Day 42. Kinetic of immune restoration through weekly measures of Absolute Lymphocyte Counts
    Time Frame Day 0 to 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Measure Participants 9 8 10
    Count of Participants [Participants]
    8
    88.9%
    7
    87.5%
    8
    80%
    2. Secondary Outcome
    Title CYT107 Effect on Absolute Lymphocyte Count
    Description Number of Patients with Absolute Lymphocyte Count > 1.2 at Day 42
    Time Frame Day 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Measure Participants 7 6 7
    Count of Participants [Participants]
    6
    66.7%
    6
    75%
    4
    40%
    3. Secondary Outcome
    Title CYT107 Immunogenicity
    Description number of patients with binding or neutralizing antibodies against CYT107 at Day 60
    Time Frame Day 60

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    Measure Participants 9 8 10
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Adverse event data were collected throughout the treatment period (Days 1-28) and through to the end of the follow-up period (Day 42).
    Adverse Event Reporting Description
    Arm/Group Title CYT107 High Frequency CYT107 Low Frequency Control
    Arm/Group Description Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for 4 weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Patients will receive Interleukin-7 (CYT107 liquid solution) at 10µg/kg twice a week for the first week, followed by CYT107 and Placebo once a week for the three following weeks Interleukin-7: IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000 Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000 Patients will receive Placebo (NaCl 0.9%) twice a week for 4 weeks Placebo: IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
    All Cause Mortality
    CYT107 High Frequency CYT107 Low Frequency Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/9 (33.3%) 1/8 (12.5%) 2/10 (20%)
    Serious Adverse Events
    CYT107 High Frequency CYT107 Low Frequency Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/9 (77.8%) 4/8 (50%) 5/10 (50%)
    Cardiac disorders
    Tamponade 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Septic embolism 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Eye disorders
    Papilledema 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Gastrointestinal disorders
    Ischemic Colitis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Bile leak 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Intra-abdominal collections 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Enterocutaneous fistula 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Evisceration 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Anastomotic leak 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Bowel perforation 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Toxic megacolon 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Wound abscess 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Vomiting 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    General disorders
    Multi organ failure 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Infections and infestations
    Mediastinitis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Relapse of endocarditis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Recurrent septic shock 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Nervous system disorders
    Ischemic stroke 1/9 (11.1%) 1 0/8 (0%) 0 1/10 (10%) 1
    Hypoglycemic coma 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Renal and urinary disorders
    Acute renal failure 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Respiratory, thoracic and mediastinal disorders
    Lung Abscess 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Acute hypoxic event 2/9 (22.2%) 2 0/8 (0%) 0 0/10 (0%) 0
    Oesophago-bronchial fistula 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Acute respiratory failure 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Tracheobronchitis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Acute respiratory distress syndrome 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Empyema 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Skin and subcutaneous tissue disorders
    Injection site reaction 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Other (Not Including Serious) Adverse Events
    CYT107 High Frequency CYT107 Low Frequency Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/9 (100%) 8/8 (100%) 7/10 (70%)
    Blood and lymphatic system disorders
    Epistaxis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Anemia 2/9 (22.2%) 2 3/8 (37.5%) 3 3/10 (30%) 3
    Ileopsoas hematoma 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Hemorrhagic shock 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Post operative bleeding 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Coagulopathy/low platelets 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Cardiac disorders
    Ventricular tachycardia 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Deep Vein Thrombosis 2/9 (22.2%) 4 1/8 (12.5%) 1 1/10 (10%) 1
    Supra ventricular tachycardia 2/9 (22.2%) 3 0/8 (0%) 0 0/10 (0%) 0
    Bradycardia 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Gastrointestinal disorders
    Hemorrhagic gastric ulcer 1/9 (11.1%) 2 0/8 (0%) 0 0/10 (0%) 0
    ischemic colitis 1/9 (11.1%) 2 0/8 (0%) 0 0/10 (0%) 0
    Gastrointestinal bleed 2/9 (22.2%) 2 0/8 (0%) 0 1/10 (10%) 1
    Diarrhea 1/9 (11.1%) 1 0/8 (0%) 0 2/10 (20%) 2
    Ascites 2/9 (22.2%) 2 0/8 (0%) 0 0/10 (0%) 0
    Ileus 2/9 (22.2%) 2 1/8 (12.5%) 1 1/10 (10%) 1
    Pressure ulcer 1/9 (11.1%) 1 1/8 (12.5%) 1 2/10 (20%) 2
    Vomiting 2/9 (22.2%) 2 0/8 (0%) 0 0/10 (0%) 0
    Dyspepsia 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Dysphagia 1/9 (11.1%) 1 0/8 (0%) 0 2/10 (20%) 2
    Wound abscess 0/9 (0%) 0 2/8 (25%) 2 0/10 (0%) 0
    GI discomfort (cramping/bloating) 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Ileal ulcer 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Intra-abdominal abscess 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    General disorders
    Persisting Fever 2/9 (22.2%) 2 0/8 (0%) 0 0/10 (0%) 0
    Fatigue 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Chills 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Fall 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Infections and infestations
    Urinary infection 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Endocarditis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Mediastinitis 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Yeast infection 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Bacteremia 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Investigations
    Cholestatis 1/9 (11.1%) 1 1/8 (12.5%) 1 0/10 (0%) 0
    High sodium 2/9 (22.2%) 2 0/8 (0%) 0 1/10 (10%) 1
    High potassium 2/9 (22.2%) 2 0/8 (0%) 0 1/10 (10%) 1
    High alkaline phosphatase 3/9 (33.3%) 3 0/8 (0%) 0 2/10 (20%) 2
    Low phosphate 2/9 (22.2%) 2 0/8 (0%) 0 0/10 (0%) 0
    Hypoglycemia 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Low Calcium 1/9 (11.1%) 1 2/8 (25%) 2 0/10 (0%) 0
    Acidosis 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    High amylase 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    High lipase 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Metabolic alkalosis 0/9 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1
    Low potassium 0/9 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1
    Low Absolute Lymphocyte Count 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Low sodium 0/9 (0%) 0 0/8 (0%) 0 2/10 (20%) 2
    High phosphorus 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Hyperglycemia 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Leukocytosis 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    High BUN 0/9 (0%) 0 0/8 (0%) 0 2/10 (20%) 2
    Thrombocytosis 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    High phosphate 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    High magnesium 0/9 (0%) 0 0/8 (0%) 0 2/10 (20%) 2
    Low BUN 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Nervous system disorders
    Confusion 1/9 (11.1%) 1 2/8 (25%) 2 1/10 (10%) 1
    Hypercapnic coma 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Cerebral sequelae of hypoglycemia 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Spasticity 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Psychiatric disorders
    Depression 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Renal and urinary disorders
    Renal failure 2/9 (22.2%) 2 1/8 (12.5%) 1 0/10 (0%) 0
    Acute renal failure 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Hepatic cytolysis 3/9 (33.3%) 4 1/8 (12.5%) 1 1/10 (10%) 1
    Respiratory, thoracic and mediastinal disorders
    Lung Abscess 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Acute hypoxic event 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Weaning failure 1/9 (11.1%) 1 0/8 (0%) 0 1/10 (10%) 1
    Acute respiratory failure 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Pleural effusion 1/9 (11.1%) 1 0/8 (0%) 0 2/10 (20%) 2
    Aspiration pneumopathy 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0
    Respiratory tract colonization 0/9 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1
    Ventilator associated pneumonia 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Empyema 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Tachypnea 0/9 (0%) 0 0/8 (0%) 0 2/10 (20%) 2
    Exp wheezing 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Acute respiratory distress syndrome 0/9 (0%) 0 0/8 (0%) 0 1/10 (10%) 1
    Skin and subcutaneous tissue disorders
    Oral herpes 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Injection site reaction 4/9 (44.4%) 7 4/8 (50%) 6 0/10 (0%) 0
    Cutaneous rash 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Necrotizing fingers 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Skin erosion 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    DRESS 1/9 (11.1%) 1 0/8 (0%) 0 0/10 (0%) 0
    Pruritis 0/9 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr Michel Morre, DVM, Chief Scientific Officer
    Organization Revimmune
    Phone +33(0)603357060
    Email m.morre@revimmune.com
    Responsible Party:
    Revimmune
    ClinicalTrials.gov Identifier:
    NCT02640807
    Other Study ID Numbers:
    • CLI-107-15
    First Posted:
    Dec 29, 2015
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Aug 1, 2018