COVID19 Pneumonia
Conditions
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.
Interventions
DRUGBevacizumab 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of surviving patients without need for intubation for respiratory support | day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial oxygen partial pressure (paO2) | day 14 | value of a healthy individual occurs between 75-100 mmHg |
| Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2) | 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 | 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 | day 28 | measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea) |
| overall survival | day 14 and 28 | — |
| Saturation of Oxygen in the blood (SaO2) | day 14 | value of a healthy individual occurs between 95 - 100 |
| 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 | — |
| admissionn to the intensive care unit (ICU) | day 14 and day 28 | — |
Contacts
Primary ContactJacques Cadranel, MD PhD
Outcome results
None listed