COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04305106

Jiaojiao Pang, Dr

jiaojiaopang@126.com

2020-03-12

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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.

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.

2

Qilu Hospital of Shandong University

18

100

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

588

The time from randomization to clinical improvement

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 197, "treatment_name": "Bevacizumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]