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
1 other identifier
interventional
130
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2020
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedApril 17, 2020
April 1, 2020
6 months
April 9, 2020
April 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of surviving patients without need for intubation for respiratory support
day 14
Secondary Outcomes (11)
Saturation of Oxygen in the blood (SaO2)
day 14
Arterial oxygen partial pressure (paO2)
day 14
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
day 14
CT-scan score
day 14
dyspnea
day 28
- +6 more secondary outcomes
Study Arms (2)
Bevacizumab
EXPERIMENTALStandard of Care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients Requiring more than 3L/min of oxygen
- WHO progression scale = 5 to 8
You may not qualify if:
- Patients in 9 WHO progression class
- Hypersensitivity to Bevacizumab or to any of their excipients.
- Pregnancy
- Active Cancer with undergoing treatment
- Oxygen patient requiring long-term oxygen before hospitalization
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 14, 2020
Study Start
April 15, 2020
Primary Completion
September 30, 2020
Study Completion
November 30, 2020
Last Updated
April 17, 2020
Record last verified: 2020-04