The Efficacy and Safety of Bevacizumab in Patients With Severe Covid-19: a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial

Status: Unknown
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Jiaojiao Pang, Dr
jiaojiaopang@126.com
18560089129
Time Frame
Start Date: 2023-01-12
Completion Date: 2023-12-31
Participants
Target number of participants: 588
Treatments
Experimental: Bevacizumab
Bevacizumab 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of 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.
Placebo_comparator: Placebo
Placebo (inactive excipient) 7.5mg/kg body weight, intravenous drip, single-dose administration, and standard of 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: Anqing Municipal Hospital, Jining First People's Hospital, Weifang Medical University, Weifang People's Hospital, First Affiliated Hospital of Wannan Medical College, First Affiliated Hospital of Wenzhou Medical University, Weihai Municipal Hospital, Zibo Municipal Hospital, Zhejing Provincial People's Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Fourth Affiliated Hospital Zhejing University School of Medicine, Jining Medical University, Rizhao People's Hospital, Weifang Second People's Hospital, Zibo Central Hospital, China-Japan Friendship Hospital, Yantai Yuhuangding Hospital, Renmin Hospital of Wuhan University, Weifang Hospital of Traditional Chinese Medicine, Linyi People's Hospital, Qingdao Municipal Hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov