Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
NCT ID: NCT04344782
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2020-04-15
2020-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab
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.
Standard of Care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* WHO progression scale = 5 to 8
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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APHP200389-7
Identifier Type: -
Identifier Source: org_study_id
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