Last updated: June 26, 2023
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting
Phase
3
Condition
Pneumonia
Covid-19
Corona Virus
Treatment
Standard care
Placebo
Bevacizumab
Clinical Study ID
NCT04305106
QLEmer
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age: ≥18 years old, both genders;
- Confirmed COVID-19 diagnosis (any body fluid tested positive for SARS-CoV-2 nucleicacid by PCR, or positive for SARS-CoV-2 antigen);
- Respiratory rate ≥ 30 times/min, partial pressure of oxygen (PaO2)/ fraction ofinspiration O2 (FiO2)≤ 300mmHg (1mmHg = 0.133kPa), or SpO2 ≤ 93% at rest withoutsupplemental oxygen;
- Article (3) above is newly appeared within 7 days;
- Chest radiography or computed tomography shows bilateral chest infiltrates.
Exclusion
Exclusion Criteria:
- Unable to obtain informed consent.
- Physician with more than 5 years of clinical experience determines that death wasinevitable 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) orreceive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Uncontrolled hypertension (sitting systolic blood pressure> 160mmHg, or diastolicblood pressure>100mmHg); previous history of hypertension crisis or hypertensiveencephalopathy.
- Poorly controlled heart diseases, such as NYHA class II and above cardiacinsufficiency, unstable angina pectoris, myocardial infarction within 1 year beforeenrollment, 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 asischemic stroke, transient ischemic attack, deep venous thrombosis, pulmonaryembolism, etc. Severe vascular disease (including aneurysms or arterial thrombosisrequiring surgery) within 6 months before enrollment.
- Unhealed wounds, active gastric ulcers or fractures. Gastrointestinal perforation,gastrointestinal fistula, abdominal abscess, visceral fistula formation within 6months before enrollment. Major surgery (including preoperative Chest biopsy) or majortrauma (such as a fracture) within 28 days before enrollment. May have surgery duringthe trial.
- Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervoussystem 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 orHIV-positive patients.
- Pregnant and lactating women and those planning to get pregnant.
- Participated in other clinical trials, not considered suitable for this study by theresearchers.
Study Design
Total Participants: 588
Treatment Group(s): 3
Primary Treatment: Standard care
Phase: 3
Study Start date:
January 12, 2023
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Qilu Hospital of Shandong University
Jinan, Shandong 250012
ChinaActive - Recruiting

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