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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Injection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of surviving patients without need for intubation for respiratory support | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Saturation of Oxygen in the blood (SaO2) | value of a healthy individual occurs between 95 - 100 | day 14 |
| Arterial oxygen partial pressure (paO2) | value of a healthy individual occurs between 75-100 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques Cadranel, MD PhD | Contact | 1 56 01 66 73 | 33 | jacques.cadranel@aphp.fr |
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| day 14 |
| Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2) | 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 | day 14 |
| CT-scan score | 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) | day 14 |
| dyspnea | measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea) | day 28 |
| overall survival | day 14 and 28 |
| admissionn to the intensive care unit (ICU) | day 14 and day 28 |
| incidence of mechanical ventilation | day 14 and day 28 |
| hospital length of stay | day 28 |
| incidence of adverse event | day 28 |
| VEGF plasma concentration | day 28 |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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