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

• Status: Not yet recruiting
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Bevacizumab

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