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

Assistance Publique - Hôpitaux de Paris130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

COVID19 Pneumonia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of surviving patients without need for intubation for respiratory support

Time frame: day 14

Secondary Outcomes

Saturation of Oxygen in the blood (SaO2)

value of a healthy individual occurs between 95 - 100

Time frame: day 14

Arterial oxygen partial pressure (paO2)

value of a healthy individual occurs between 75-100 mmHg

Time frame: 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

Time frame: 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)

Time frame: day 14

dyspnea

measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)

Time frame: day 28

overall survival

Time frame: day 14 and 28

admissionn to the intensive care unit (ICU)

Time frame: day 14 and day 28

incidence of mechanical ventilation

Time frame: day 14 and day 28

hospital length of stay

Time frame: day 28

incidence of adverse event

Time frame: day 28

VEGF plasma concentration

Time frame: day 28

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts