Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort (CORIMMUNO-BEVA)
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|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
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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.
|Condition or disease||Intervention/treatment||Phase|
|COVID19 Pneumonia||Drug: Bevacizumab Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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|
- Proportion of surviving patients without need for intubation for respiratory support [ Time Frame: day 14 ]
- Saturation of Oxygen in the blood (SaO2) [ Time Frame: day 14 ]value of a healthy individual occurs between 95 - 100
- Arterial oxygen partial pressure (paO2) [ Time Frame: day 14 ]value of a healthy individual occurs between 75-100 mmHg
- 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
- 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)
- dyspnea [ Time Frame: day 28 ]measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
- overall survival [ Time Frame: day 14 and 28 ]
- admissionn to the intensive care unit (ICU) [ Time Frame: day 14 and day 28 ]
- incidence of mechanical ventilation [ Time Frame: day 14 and day 28 ]
- hospital length of stay [ Time Frame: day 28 ]
- incidence of adverse event [ Time Frame: day 28 ]
- VEGF plasma concentration [ Time Frame: day 28 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients Requiring more than 3L/min of oxygen
- WHO progression scale = 5 to 8
- Patients in 9 WHO progression class
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Hypersensitivity to Bevacizumab or to any of their excipients.
- 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
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
|Contact: Jacques Cadranel, MD PhD||1 56 01 66 73 ext email@example.com|
|Responsible Party:||Assistance Publique - Hôpitaux de Paris|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Angiogenesis Modulating Agents
Physiological Effects of Drugs