A Phase 3 interventional study of BEVA+SOC and SOC in Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome) and Virus Diseases, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 96 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Bevacizumab : 7.5 mg / kg (with a maximum of 750 mg) on day 1 (D1) SOC : patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
Drug: BEVA+SOC
SOC : patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
Drug: SOC
Bevacizumab : 7.5 mg / kg (with a maximum of 750 mg) on day 1 (D1) SOC : patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
The time to recovery for a category 0 to 5 on the WHO Progression scale
Defined as the first day on which the patient meets the criteria for category 0 to 5 on the OMS Progression scale
Time frame: 28 days after randomization
Clinical status on the OMS Progression scale
WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\>=150 OR SpO2/FIO2\>=200: 7 Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) OR vasopressors (norepinephrine \>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\<150 AND vasopressors (norepinephrine \>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Time frame: at 7, 14, and 28 days after randomization
Overall survival
Time to death after randomization
Time frame: at 7, 14, and 28 days after randomization
Ventilator free days
Time frame: at 7, 14, and 28 days after randomization
High flow free days
Time frame: at 7, 14, and 28 days after randomization
Time to oxygen supply weaning
Time frame: at 7, 14, and 28 days after randomization
Changes in VEGF plasma levels
Time frame: at 7, and 14 days after randomization
Comparison of the incidence of Grade 3 or 4 events will be will be described in each group with their 95% CI
Description : defined according to CTCAE v5.0 will be will be described in each group with their 95% CI
Time frame: Day 28
Proportion of Adverse Event
will be described in each group with their 95% CI
Time frame: Day 28, day 120 after randomization
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris