Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia (BEST-CP)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04275414|
Recruitment Status : Completed
First Posted : February 19, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infections||Drug: Bevacizumab Injection||Phase 2|
In December 2019, a new identified coronavirus (SARS-CoV-2) outbreak in Wuhan, causes public health crisis in China and spreads worldwide. On February 11,2020, the World Health Organization officially named the disease caused by the new coronavirus "COVID-19". The Chinese Government takes stronger and harsher measures to control the progression of its outbreak. Meanwhile, five editions of "Diagnosis and Treatment for Novel Coronavirus-Infected Pneumonia" has been timely and continuously issued, which play extremely important roles in guiding the clinical management of COVID-19 nationwide in China.
The symptoms of human infection with SARS-CoV-2 are generally fever, fatigue, dry cough and dyspnea. Noteworthy, a considerable percentage of COVID-19 cases have rapidly progressed to severe and critical type, among which acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are the most common complications, resulting in a large number of pneumonia hospitalized patients requiring supplemental oxygen, mechanical ventilation, or even ECMO.Pulmonary edema is a detrimental feature as well as a key causal factor of ALI/ARDS.
Vascular Endothelial Growth Factor (VEGF) is considered as the most potent vascular permeability inducers. Recent evidence has revealed higher VEGF levels in COVID-19 patients compared with healthy controls. The rise of VEGF levels may be caused by hypoxia, severe inflammation, and upregulation of the infected respiratory tract epithelium itself. Numerous studies have confirmed a key role of VEGF as potential therapeutic target in acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) due do increase vascular permeability and induce pulmonary edema.
Thus, Bevacizumab, an anti-VEGF medication, may offer a unique approach to treat ALI/ARDS caused by COVID-19. Bevacizumab is a humanized monoclonal antibody with long half-life. It has been approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, with the pharmacokinetics and pharmacodynamics having been widely understood. Therefore, Bevacizumab is a promising drug for the treatment of ALI/ARDS as well as reduction of mortality in severe and critical COVID-19 patients through suppression of pulmonary edema.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effecacy and Safety of Bevacizumab in Severe Patients With Covid-19: a Pilot Study (BEST-CP)|
|Actual Study Start Date :||February 15, 2020|
|Actual Primary Completion Date :||April 5, 2020|
|Actual Study Completion Date :||May 2, 2020|
Experimental: bevacizumab plus standard care
Under ECG monitoring, give bevacizumab 500mg + 0.9% sodium chloride solution 100ml via intravenous drip, time is no less than 90min.
Drug: Bevacizumab Injection
Bevacizumab 500mg + normal saline (NS) 100ml, ivdrip ≥90min
- Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 24 hours ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
- Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio [ Time Frame: 7 days ]Partial arterial oxygen pressure (PaO2) to fraction of inspiration O2 (FiO2) ratio
- Rate of improvement of oxygen-support status [ Time Frame: 28 days ]The oxygen-support status includes 6 levels: mechanical ventilation, non-invasive ventilation, a transition status of alternate use of non-invasive ventilation and high-flow oxygen, high-flow oxygen, low-flow oxygen and ambient air. The improvement of oxygen-support status is defined as switch from a higher level of oxygen-support to a lower level.
- The change of areas of pulmonary lesions shown on chest radiological imaging (chest CT or X-ray) [ Time Frame: 7 days ]The areas of pulmonary lesions are analysised by a professional imaging software.
- Blood lymphocyte counts [ Time Frame: 7 days ]Blood lymphocyte counts
- Level of CRP [ Time Frame: 7 days ]Level of CRP
- Level of hs-CRP [ Time Frame: 7 days ]Level of hs-CRP
- All-cause mortality [ Time Frame: 28 days ]All-cause mortality
- Discharge rate [ Time Frame: 28 days ]Discharge rate
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): NCT04275414
|Renmin Hospital of Wuhan University|
|Wuhan, Hubei, China|
|Qilu Hospital of Shandong University|
|Jinan, Shandong, China, 250012|
|Moriggia-Pelascini Gravedona Hospital|
|Principal Investigator:||Yuguo Chen, Dr||Qilu Hospital of Shandong University|