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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

Group Type EXPERIMENTAL

Bevacizumab Injection

Intervention Type DRUG

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

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients Requiring more than 3L/min of oxygen
* WHO progression scale = 5 to 8

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jacques Cadranel, MD PhD

Role: CONTACT

1 56 01 66 73 ext. 33

Other Identifiers

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APHP200389-7

Identifier Type: -

Identifier Source: org_study_id

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