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
About this trial
This is an interventional treatment trial for COVID19 Pneumonia
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
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
NCT ID
NCT04344782
First Posted
April 9, 2020
Last Updated
April 16, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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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