Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT
Kľúčové slová
Abstrakt
Termíny
Naposledy overené: | 02/29/2020 |
Prvý príspevok: | 03/08/2020 |
Odhadovaná registrácia bola odoslaná: | 03/08/2020 |
Prvý príspevok: | 03/11/2020 |
Posledná aktualizácia bola odoslaná: | 03/23/2020 |
Posledná aktualizácia bola zverejnená: | 03/25/2020 |
Aktuálny dátum začatia štúdie: | 03/16/2020 |
Odhadovaný dátum dokončenia primárneho okruhu: | 06/29/2020 |
Odhadovaný dátum dokončenia štúdie: | 07/30/2020 |
Stav alebo choroba
Intervencia / liečba
Drug: Bevacizumab Group
Fáza
Skupiny zbraní
Arm | Intervencia / liečba |
---|---|
Experimental: Bevacizumab Group | Drug: Bevacizumab Group Bevacizumab 7.5mg/kg body weight + 0.9% NaCl 100ml, intravenous drip |
No Intervention: Control Group |
Kritériá oprávnenosti
Vek vhodný na štúdium | 18 Years To 18 Years |
Pohlavia vhodné na štúdium | All |
Prijíma zdravých dobrovoľníkov | Áno |
Kritériá | Inclusion Criteria: 1. Age: 18-80 years old, male and female; 2. Covid-19 confirmed cases; 3. Comply with any of the following: - Dyspnea, RR ≥ 30 times / min; - In resting state, transcutaneous oxygen saturation ≤ 93%; - Oxygenation index (PaO2 / FiO2) < 300MMHG; 4. Pulmonary imaging showed diffuse exudative lesions. Exclusion Criteria: 1. Unable to obtain informed consent; 2. Patients with severe liver dysfunction (Child Pugh score ≥ C, or AST > 5 times of the upper limit), severe renal dysfunction (estimated glomerular filtration rate ≤ 30ml / min / 1.73 m2), or continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 3. Patients with hypertension and unsatisfactory control of antihypertensive drugs (sitting systolic blood pressure > 160mmHg, or diastolic blood pressure > 100mmHg) had a history of hypertension crisis or hypertensive encephalopathy; 4. Patients with heart disease or clinical symptoms that can not be well controlled, such as NYHA class II or above of cardiac insufficiency, unstable angina, myocardial infarction within one year, supraventricular or ventricular arrhythmias need treatment or intervention; 5. Those with known hereditary bleeding tendency or coagulation dysfunction, those who had received full dose anticoagulant or thrombolytic therapy in the first 10 days of the group, or those who had taken nonsteroidal anti-inflammatory drugs with platelet inhibition in the first 10 days of the group (except those who had preventive use of low-dose aspirin ≤ 325mg / day); 6. In the first 6 months of the group, the patients who had thrombosis, such as ischemic stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism and other thrombotic diseases, and in the first 6 months of the group, the patients who had serious angiopathy (including aneurysms or arterial thrombosis requiring surgical treatment) were screened; 7. Patients with unhealed wounds, active gastric ulcer or fracture; patients with gastrointestinal perforation, gastrointestinal fistula, abdominal abscess and internal fistula in the first 6 months of the group; patients with major surgical history (including thoracotomy biopsy), major trauma (such as fracture) or possible surgery in the course of participating in the trial within 28 days before the group; 8. There were hemoptysis, gastrointestinal bleeding, central nervous system bleeding, nose bleeding and other serious and active bleeding patients within one month before admission; 9. There were malignant tumors in the past 5 years; 10. Those allergic to bevacizumab and its components; 11. Untreated active hepatitis patients and HIV positive patients; 12. Pregnant women, lactating women and planned pregnant women; 13. Have participated in other clinical trials or the researchers think it is not suitable to participate in this study. |
Výsledok
Primárne výstupné opatrenia
1. The time from randomization to clinical improvement [No more than 28 days]