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

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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

Tracking Information
First Submitted Date  ICMJE March 9, 2020
First Posted Date  ICMJE March 12, 2020
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE March 17, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
Proportion of patients whose oxygenation index increased by 100mmhg on the 7th day after admission [ Time Frame: On the 7th day after admission ]
Proportion of patients whose oxygenation index increased by 100mmhg on the 7th day after admission
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT
Official Title  ICMJE The Efficacy and Safety of Bevacizumab in Severe or Critical Patients With COVID-19--a Multicenter Randomized Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE Drug: Bevacizumab
Bevacizumab 7.5mg/kg body weight + 0.9% NaCl 100ml, intravenous drip
Study Arms  ICMJE
  • Experimental: Bevacizumab Group
    Intervention: Drug: Bevacizumab
  • No Intervention: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
118
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiaojiao Pang, Dr 18560089129 jiaojiaopang@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04305106
Other Study ID Numbers  ICMJE QLEmer
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qilu Hospital of Shandong University
Study Sponsor  ICMJE Qilu Hospital of Shandong University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Yihai Cao, Dr Qilu Hospital of Shandong University, Karolinska Institutet
Principal Investigator: Yuguo Chen, Dr Qilu Hospital of Shandong University
PRS Account Qilu Hospital of Shandong University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP