Bevacizumab in Patients With Severe Covid-19

Summary

The novel coronavirus (SARS-CoV-2) is a new strain of coronavirus found in human in 2019, which causes epidemic worldwide. Novel coronavirus disease (COVID-19) causes acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe COVID-19. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patients died from COVID-19 reported that, pulmonary mucus exudation was more severe and obvious than SARS infection. Pulmonary CT scanning and pathological findings also suggest that pulmonary edema caused by inflammatory exudation is a distinguished feature of COVID-19. Vascular endothelial growth factor (VEGF), also known as vascular permeability factor (VPF), is known as the most potent factor to increase vascular permeability, with the induction effect 50,000 times stronger than histamine. Bevacizumab is an anti-VEGF recombinant humanized monoclonal antibody, which has been used in anti-tumor treatment since 2004, with considerable reliability and clinical safety. This trial will provide high level evidence to answer whether bevacizumab is efficacy and safe medication for patients with severe COVID-19.

Conditions

• COVID-19 Pneumonia

Interventions

DRUG

Bevacizumab

Bevacizumab (7.5mg/kg BW) + Saline (100ml) Bevacizumab will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring.

OTHER

Placebo

Placebo (7.5mg/kg BW) + Saline (100ml) The placebo drug will be administered in a single dose with no less than 90 minutes of intravenous infusion under ECG monitoring.

OTHER

Standard care

Standard care, including prophylactic doses of low molecular weight heparin or unfractionated heparin without contraindications, and therapeutic doses of anticoagulants with the evidence of thrombosis risk or occurrence.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Zhejing Provincial People's Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Anqing Municipal Hospital

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• The Fourth Affiliated Hospital Zhejing University School of Medicine

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Linyi People's Hospital

  collaborator OTHER

• Jining Medical University

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Weifang Second People's Hospital

  collaborator UNKNOWN

• Weifang Medical University

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Weihai Municipal Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Weifang Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Zibo Central Hospital

  collaborator OTHER_GOV

• Zibo Municipal Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  lead OTHER

Principal Investigators

• Yihai Cao, Dr · Qilu Hospital of Shandong University, Karolinska Institutet

• Yuguo Chen, Dr · Qilu Hospital of Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-12

Primary Completion

2023-11-30

Completion

2023-12-31

Countries

• China

Study Locations