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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344782
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID19 Pneumonia Drug: Bevacizumab Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bevacizumab 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.
No Intervention: Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of surviving patients without need for intubation for respiratory support [ Time Frame: day 14 ]

Secondary Outcome Measures :
  1. Saturation of Oxygen in the blood (SaO2) [ Time Frame: day 14 ]
    value of a healthy individual occurs between 95 - 100

  2. Arterial oxygen partial pressure (paO2) [ Time Frame: day 14 ]
    value of a healthy individual occurs between 75-100 mmHg

  3. Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2) [ Time Frame: day 14 ]
    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

  4. CT-scan score [ Time Frame: day 14 ]
    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)

  5. dyspnea [ Time Frame: day 28 ]
    measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)

  6. overall survival [ Time Frame: day 14 and 28 ]
  7. admissionn to the intensive care unit (ICU) [ Time Frame: day 14 and day 28 ]
  8. incidence of mechanical ventilation [ Time Frame: day 14 and day 28 ]
  9. hospital length of stay [ Time Frame: day 28 ]
  10. incidence of adverse event [ Time Frame: day 28 ]
  11. VEGF plasma concentration [ Time Frame: day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344782


Contacts
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Contact: Jacques Cadranel, MD PhD 1 56 01 66 73 ext 33 jacques.cadranel@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04344782    
Other Study ID Numbers: APHP200389-7
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors