Pilot study of single-dose bevacizumab as a treatment for acute respiratory distress syndrome in patients with COVID-19

Fundación para la Investigación Biomédica de Córdoba0 个研究点目标入组 22 人开始时间: 2020年4月27日最近更新: 2023年9月26日

试验速览

暂无简介。

•1. Age = 18 and <90 years
•2. Diagnosis confirmed by COVID-19 PCR
•3. Radiological image compatible with bilateral non-cardiogenic pleuropulmonary exudate
•4. Having received antiviral and anti-inflammatory therapy according to the protocol of the Reina Sofía University Hospital in Córdoba
•5. Present any of the following clinical-functional criteria:
•5.a. Respiratory distress: Tachypnea> 30 breaths / minute
•5.b. Partial arterial oxygen pressure (PaO2) / Inspiration fraction (FiO2) = 300 mmHg
•6. Signature of direct or delegated informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1. Severe liver dysfunction (Child Pugh = 3 or AST> 5 times normal)
•2. Severe renal dysfunction with glomerular filtration <30 mL / minute or in treatment with hemodialysis or peritoneal dialysis)
•3. Poorly controlled arterial hypertension (TAs> 160 mmHg or TAd <100 mmHg) or having a previous history of hypertensive crisis or hypertensive encephalopathy
•4. History of poorly controlled heart disease with a NYHA> 2
•5. History of thrombosis the previous 6 months
•6. Signs of active bleeding
•7. Open wounds, gastrointestinal perforation fractures
•8. Diagnosis of thrombophilic diseases or bleeding diathesis
•9. Active viral hepatitis or HIV not adequately treated
•10. Intolerance or allergy to bevacizumab or its components
•11. Pregnancy

发起方

Fundación para la Investigación Biomédica de Córdoba