Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04822818
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2021-03-25
Brief Title:
EFFICACY and SAFETY OF BEVACIZUMAB ZIRABEV IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
TRIAL EVALUATING EFFICACY and SAFETY OF BEVACIZUMAB ZIRABEV IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19 NESTED IN THE CORIMUNO-19 COHORT
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEVA
Brief Summary:
Acute lung injury ALI and acute respiratory distress syndrome ARDS are the most frequent complications of the COVID-19 pandemic In these conditions hypoxemia may result from i a pulmonary vascular dilatation resulting from an impaired hypoxic pulmonary vasoconstriction and leading to ventilation-perfusion mismatching within the lungs and ii thrombosis-mediated perfusion defects Pulmonary vascular dilation might be due to a relative failure of the physiological acute hypoxic pulmonary vasoconstriction in the context of an over-activation of a regional vasodilatation cascade as part of a dysfunctional inflammatory process Perfusion abnormalities associated with pulmonary vascular dilation are suggestive of intrapulmonary shunting toward areas where gas exchange is impaired ultimately leading to a worsening ventilation-perfusion mismatch a regional hypoxia and a profound hypoxemia
Increased plasma levels of VEGF have been reported in moderate to severe COVID-19 pneumonia highlighting the role of VEGF in the pathophysiology of the disease A better prognosis has been reported in critically ill patients with lower levels of growth factors HGF and VEGF-A at the time of ICU admission Recent data of the study NCT 04275414 by Pang J et al have suggested that patients receiving a single-dose of bevacizumab have improved their oxygen support status in 92 of cases during a 28-day follow-up period as compared with 62 of cases in an external cohort receiving standard care
Correcting endothelial permeability and vasodilatation with VEGF-targeted therapy could allow repair damaged vascular endothelium have an indirect anti-inflammatory effect limiting alveolar exudation of circulating inflammatory and procoagulant mediators and improve oxygenation and therefore reduce the proportion of patients with severe forms requiring ICU referral and finally patient death This clinical trial will therefore focus on the specific efficacy of bevacizumab in COVID-19 patients with severe hypoxemia
Increased plasma levels of VEGF have been reported in moderate to severe COVID-19 pneumonia highlighting the role of VEGF in the pathophysiology of the disease A better prognosis has been reported in critically ill patients with lower levels of growth factors HGF and VEGF-A at the time of ICU admission Recent data of the study NCT 04275414 by Pang J et al have suggested that patients receiving a single-dose of bevacizumab have improved their oxygen support status in 92 of cases during a 28-day follow-up period as compared with 62 of cases in an external cohort receiving standard care
Correcting endothelial permeability and vasodilatation with VEGF-targeted therapy could allow repair damaged vascular endothelium have an indirect anti-inflammatory effect limiting alveolar exudation of circulating inflammatory and procoagulant mediators and improve oxygenation and therefore reduce the proportion of patients with severe forms requiring ICU referral and finally patient death This clinical trial will therefore focus on the specific efficacy of bevacizumab in COVID-19 patients with severe hypoxemia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None