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Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort (CORIMMUNO-BEVA)

Primary Purpose

COVID19 Pneumonia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab Injection
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients Requiring more than 3L/min of oxygen
  • WHO progression scale = 5 to 8

Exclusion Criteria:

  • Patients in 9 WHO progression class
  • Patients with exclusion criteria to the CORIMUNO-19 cohort.
  • Hypersensitivity to Bevacizumab or to any of their excipients.
  • Pregnancy
  • Active Cancer with undergoing treatment
  • Oxygen patient requiring long-term oxygen before hospitalization
  • Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator.
  • Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery.
  • Hypersensitivity to the active substance or one of the excipients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Bevacizumab

    Standard of Care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of surviving patients without need for intubation for respiratory support

    Secondary Outcome Measures

    Saturation of Oxygen in the blood (SaO2)
    value of a healthy individual occurs between 95 - 100
    Arterial oxygen partial pressure (paO2)
    value of a healthy individual occurs between 75-100 mmHg
    Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
    Normal level should be >500 Index of severity of acute respiratory distress syndrome (ARDS) mild if 200-300 moderate if 100-200 severe if < 200
    CT-scan score
    based on a Likert scale with scores ranging from 1 to 5 (1-definitely no; 2-probably no; 3-equivocal; 4-probably yes; 5-definitely yes)
    dyspnea
    measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
    overall survival
    admissionn to the intensive care unit (ICU)
    incidence of mechanical ventilation
    hospital length of stay
    incidence of adverse event
    VEGF plasma concentration

    Full Information

    First Posted
    April 9, 2020
    Last Updated
    April 16, 2020
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04344782
    Brief Title
    Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
    Acronym
    CORIMMUNO-BEVA
    Official Title
    Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2020 (Anticipated)
    Study Completion Date
    November 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units. This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID19 Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bevacizumab
    Arm Type
    Experimental
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab Injection
    Intervention Description
    Treatment includes the administration on day 1 (D1) of an infusion of Bevacizumab 7.5 mg / kg in 100 ml saline for all patients weighing 100 kg or more. In control arm, patient receives standard care.
    Primary Outcome Measure Information:
    Title
    Proportion of surviving patients without need for intubation for respiratory support
    Time Frame
    day 14
    Secondary Outcome Measure Information:
    Title
    Saturation of Oxygen in the blood (SaO2)
    Description
    value of a healthy individual occurs between 95 - 100
    Time Frame
    day 14
    Title
    Arterial oxygen partial pressure (paO2)
    Description
    value of a healthy individual occurs between 75-100 mmHg
    Time Frame
    day 14
    Title
    Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
    Description
    Normal level should be >500 Index of severity of acute respiratory distress syndrome (ARDS) mild if 200-300 moderate if 100-200 severe if < 200
    Time Frame
    day 14
    Title
    CT-scan score
    Description
    based on a Likert scale with scores ranging from 1 to 5 (1-definitely no; 2-probably no; 3-equivocal; 4-probably yes; 5-definitely yes)
    Time Frame
    day 14
    Title
    dyspnea
    Description
    measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
    Time Frame
    day 28
    Title
    overall survival
    Time Frame
    day 14 and 28
    Title
    admissionn to the intensive care unit (ICU)
    Time Frame
    day 14 and day 28
    Title
    incidence of mechanical ventilation
    Time Frame
    day 14 and day 28
    Title
    hospital length of stay
    Time Frame
    day 28
    Title
    incidence of adverse event
    Time Frame
    day 28
    Title
    VEGF plasma concentration
    Time Frame
    day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients Requiring more than 3L/min of oxygen WHO progression scale = 5 to 8 Exclusion Criteria: Patients in 9 WHO progression class Patients with exclusion criteria to the CORIMUNO-19 cohort. Hypersensitivity to Bevacizumab or to any of their excipients. Pregnancy Active Cancer with undergoing treatment Oxygen patient requiring long-term oxygen before hospitalization Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator. Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery. Hypersensitivity to the active substance or one of the excipients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacques Cadranel, MD PhD
    Phone
    1 56 01 66 73
    Ext
    33
    Email
    jacques.cadranel@aphp.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort

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