Status:
COMPLETED
Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Renmin Hospital of Wuhan University
Moriggia-Pelascini Gravedona Hospital
Conditions:
Coronavirus Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental sympt...
Detailed Description
In December 2019, a new identified coronavirus (SARS-CoV-2) outbreak in Wuhan, causes public health crisis in China and spreads worldwide. On February 11,2020, the World Health Organization officially...
Eligibility Criteria
Inclusion
- Age 18 to 80.
- Confirmed COVID-19 diagnosis(including the clinically confirmed cases in Hubei).
- Accord with any of the following: respiratory distress, RR ≥ 30 breaths/min; or SpO2 ≤ 93% at rest; or partial arterial oxygen pressure (PaO2) / fraction of inspiration O2 (FiO2) \>100mmHg and ≤ 300mmHg (1mmHg = 0.133kPa).
- Chest imaging confirms lung involvement and has inflammatory exudation or pleural effusion.
Exclusion
- Cannot obtain informed consent.
- 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.
- Unsatisfactory controlled hypertension (seated 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.
- Hereditary bleeding tendency or coagulopathy; received full-dose anticoagulant or thrombolytic therapy within10 days before enrollment, or have taken non-steroidal anti-inflammatory drugs with platelet suppression within 10 days before enrollment (Except those who use small doses of aspirin ≤325mg / day for preventive use).
- Thrombosis within 6 months before enrollment. And from those patients, screen who had arterial / venous thromboembolic events, such as, ischemic stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, etc. within 1 year ahead of enrollment. 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.
- 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 :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04275414
Start Date
February 15 2020
End Date
May 2 2020
Last Update
September 14 2020
Active Locations (3)
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1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
2
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
3
Moriggia-Pelascini Gravedona Hospital
Gravedona, Italy