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

Assistance Publique - Hôpitaux de Paris

Status and phase

Unknown

Phase 2

Conditions

COVID19 Pneumonia

Treatments

Drug: Bevacizumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04344782

APHP200389-7

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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