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

Study Overview
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Brief Summary
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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.

Official Title
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Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial

Conditions
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COVID19 Pneumonia

Intervention / Treatment
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* Drug: Bevacizumab Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br> | Drug: Bevacizumab Injection<br>* 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.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of surviving patients without need for intubation for respiratory support |  | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saturation of Oxygen in the blood (SaO2) | value of a healthy individual occurs between 95 - 100 | day 14 | 
| Arterial oxygen partial pressure (paO2) | value of a healthy individual occurs between 75-100 mmHg | day 14 | 
| 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 | day 14 | 
| 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) | day 14 | 
| dyspnea | measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea) | day 28 | 
| overall survival |  | day 14 and 28 | 
| admissionn to the intensive care unit (ICU) |  | day 14 and day 28 | 
| incidence of mechanical ventilation |  | day 14 and day 28 | 
| hospital length of stay |  | day 28 | 
| incidence of adverse event |  | day 28 | 
| VEGF plasma concentration |  | day 28 |