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

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

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 Overview

• Status: Unknown
• Conditions: COVID19 Pneumonia
• Intervention / Treatment: Drug: Bevacizumab Injection

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacques Cadranel, MD PhD; Phone Number: 33 1 56 01 66 73; Email: jacques.cadranel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab	Drug: Bevacizumab Injection; 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.
No Intervention: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: APHP200389-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No