Status:
COMPLETED
EFFICACY and SAFETY OF BEVACIZUMAB (ZIRABEV®) IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Corona Virus Infection
SARS (Severe Acute Respiratory Syndrome)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 vas...
Eligibility Criteria
Inclusion
- Patients included in the CORIMUNO-19 cohort
- Patients hospitalized in conventional ward or in the ICU belonging to the following groups: OMS Progression scale 6, 7, 8 AND no acute pulmonary embolism on CT-scan performed in the preceding 72 hours no pulmonary evident bacterial coinfection or superinfection evaluated by non-invasive procedures (serology, antigens, nasopharynx PCR, sputum examination, blood cultures…)
Exclusion
- Patients in OMS progression class 9
- Patients with exclusion criteria to the CORIMUNO-19 cohort
- Pregnancy
- Active cancer with ongoing treatment
- acute use of NIV for COPD exacerbation or cardiac decompensation associated to COVID-19
- Oxygen patient requiring long-term oxygen before hospitalization
- Patient already included in an interventional research
- Risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery during the last 3 weeks
- Hypersensitivity to the active substance (bevacizumab) or to any of the excipients (sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, water for injection
- Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
- Persistant uncontrolled arterial hypertension after using to anti-hypertensive drugs
- Current documented bacterial infection not controlled by antibiotics.
- Active viral diseases (especially active herpes, chickenpox, shingles),
- Active tuberculosis or disseminated strongyloidiasis
- patient with known active hepatitis or with increased level of SGOT or SGPT ≥5N
- Patient with anormal laboratory results: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) \< 50 G /L
Key Trial Info
Start Date :
April 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04822818
Start Date
April 17 2021
End Date
July 11 2022
Last Update
December 28 2022
Active Locations (1)
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1
Hôpital TENON
Paris, France