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

COVID19 Pneumonia Clinical Trial

— CORIMMUNO-BEVA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344782
• Other study ID #: APHP200389-7
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jacques Cadranel, MD PhD
• Phone: 1 56 01 66 73
• Email: jacques.cadranel[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID19 Pneumonia
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of surviving patients without need for intubation for respiratory support		day 14
Secondary	Saturation of Oxygen in the blood (SaO2)	value of a healthy individual occurs between 95 - 100	day 14
Secondary	Arterial oxygen partial pressure (paO2)	value of a healthy individual occurs between 75-100 mmHg	day 14
Secondary	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
Secondary	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
Secondary	dyspnea	measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)	day 28
Secondary	overall survival		day 14 and 28
Secondary	admissionn to the intensive care unit (ICU)		day 14 and day 28
Secondary	incidence of mechanical ventilation		day 14 and day 28
Secondary	hospital length of stay		day 28
Secondary	incidence of adverse event		day 28
Secondary	VEGF plasma concentration		day 28