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Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT (BEST-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305106
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : March 26, 2020
Sponsor:
Collaborators:
Renmin Hospital of Wuhan University
Ialy Moriggia Pelascini Gravedona Hospital S.p.A
Wuhan University
Jiangbei Union Hospital of Huazhong University of science and technology
Shandong Provincial Chest Hospital
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Brief 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 the severe and critically severe patients. Pulmonary edema is the key detrimental feature of ALI/ARDS. Autopsy of patients died from COVID-19 reported that, pulmonary mucus exudation was severe, more 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. However, specific pharmacotherapy is lacking.Vascular endothelial growth factor (VEGF) is known as the most potent inducing factors to increase vascular permeability. Bevacizumab is an anti VEGF recombinant humanized monoclonal antibody, which has been used in anti-tumor treatment for 16 years. Evidence suggest that Bevacizumab is a promising drug for severe and critical COVID-19 patients.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Bevacizumab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Bevacizumab in Severe or Critical Patients With COVID-19--a Multicenter Randomized Controlled Clinical Trial
Actual Study Start Date : March 17, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab Group Drug: Bevacizumab
Bevacizumab 7.5mg/kg body weight + 0.9% NaCl 100ml, intravenous drip

No Intervention: Control Group



Primary Outcome Measures :
  1. The time from randomization to clinical improvement [ Time Frame: No more than 28 days ]
    The time from randomization to an improvement of two points on a seven-category ordinal scale or live discharge from the hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305106


Contacts
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Contact: Jiaojiao Pang, Dr 18560089129 jiaojiaopang@126.com

Locations
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China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Jiaojiao Pang, Dr    +86 18560089129    jiaojiaopang@126.com   
Sponsors and Collaborators
Qilu Hospital of Shandong University
Renmin Hospital of Wuhan University
Ialy Moriggia Pelascini Gravedona Hospital S.p.A
Wuhan University
Jiangbei Union Hospital of Huazhong University of science and technology
Shandong Provincial Chest Hospital
Investigators
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Principal Investigator: Yihai Cao, Dr Qilu Hospital of Shandong University, Karolinska Institutet
Principal Investigator: Yuguo Chen, Dr Qilu Hospital of Shandong University
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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04305106    
Other Study ID Numbers: QLEmer
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors