Status:
UNKNOWN
Bevacizumab in Patients With Severe Covid-19
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
China-Japan Friendship Hospital
Renmin Hospital of Wuhan University
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute...
Detailed Description
Evident increase of VEGF levels in serum has been displayed on novel pneumonia patients. The investigators also conducted a pilot study of 93 patients with severe COVID-19 that confirmed the significa...
Eligibility Criteria
Inclusion
- Age: ≥18 years old, both genders;
- Confirmed COVID-19 diagnosis (any body fluid tested positive for SARS-CoV-2 nucleic acid by PCR, or positive for SARS-CoV-2 antigen);
- Respiratory rate ≥ 30 times/min, partial pressure of oxygen (PaO2)/ fraction of inspiration O2 (FiO2)≤ 300mmHg (1mmHg = 0.133kPa), or SpO2 ≤ 93% at rest without supplemental oxygen;
- Article (3) above is newly appeared within 7 days;
- Chest radiography or computed tomography shows bilateral chest infiltrates.
Exclusion
- Unable to obtain informed consent.
- Physician with more than 5 years of clinical experience determines that death was inevitable within 24 hours.
- Severe hepatic dysfunction (Child Pugh score ≥ C, or AST\> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate ≤ 30mL/ min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Uncontrolled hypertension (sitting systolic blood pressure\> 160mmHg, or diastolic blood pressure\>100mmHg); previous history of hypertension crisis or hypertensive encephalopathy.
- Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
- Severe or above chronic obstructive pulmonary disease (GOLD grade, FEV1/FVC \< 0.5).
- Hereditary bleeding tendency or coagulopathy;
- Arterial/venous thromboembolic events within 6 months before enrollment, such as ischemic stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, etc. Severe vascular disease (including aneurysms or arterial thrombosis requiring surgery) within 6 months before enrollment.
- Unhealed wounds, active gastric ulcers or fractures. Gastrointestinal perforation, gastrointestinal fistula, abdominal abscess, visceral fistula formation within 6 months before enrollment. Major surgery (including preoperative Chest biopsy) or major trauma (such as a fracture) within 28 days before enrollment. May have surgery during the trial.
- Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.
- Malignant tumors within 5 years before enrollment.
- Allergic to bevacizumab or its components.
- Active tuberculosis, uncontrollable infection, untreated active hepatitis or HIV-positive patients.
- Pregnant and lactating women and those planning to get pregnant.
- Participated in other clinical trials, not considered suitable for this study by the researchers.
Key Trial Info
Start Date :
January 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT04305106
Start Date
January 12 2023
End Date
December 31 2023
Last Update
June 27 2023
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012