Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT (BEST-RCT)
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ClinicalTrials.gov Identifier: NCT04305106 |
Recruitment Status : Unknown
Verified March 2020 by Qilu Hospital of Shandong University.
Recruitment status was: Recruiting
First Posted : March 12, 2020
Last Update Posted : March 26, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 Pneumonia | Drug: Bevacizumab | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Bevacizumab Group |
Drug: Bevacizumab
Bevacizumab 7.5mg/kg body weight + 0.9% NaCl 100ml, intravenous drip |
No Intervention: Control Group |
- 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

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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 |
Inclusion Criteria:
- Age: 18-80 years old, male and female;
- Covid-19 confirmed cases;
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Comply with any of the following:
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Dyspnea, RR ≥ 30 times / min;
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In resting state, transcutaneous oxygen saturation ≤ 93%;
- Oxygenation index (PaO2 / FiO2) < 300MMHG;
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- Pulmonary imaging showed diffuse exudative lesions.
Exclusion Criteria:
- Unable to obtain informed consent;
- 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;
- 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;
- 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;
- 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);
- 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;
- 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;
- There were hemoptysis, gastrointestinal bleeding, central nervous system bleeding, nose bleeding and other serious and active bleeding patients within one month before admission;
- There were malignant tumors in the past 5 years;
- Those allergic to bevacizumab and its components;
- Untreated active hepatitis patients and HIV positive patients;
- Pregnant women, lactating women and planned pregnant women;
- Have participated in other clinical trials or the researchers think it is not suitable to participate in this study.

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
Contact: Jiaojiao Pang, Dr | 18560089129 | jiaojiaopang@126.com |
China, Shandong | |
Qilu Hospital of Shandong University | Recruiting |
Jinan, Shandong, China, 250012 | |
Contact: Jiaojiao Pang, Dr +86 18560089129 jiaojiaopang@126.com |
Principal Investigator: | Yihai Cao, Dr | Qilu Hospital of Shandong University, Karolinska Institutet | |
Principal Investigator: | Yuguo Chen, Dr | Qilu Hospital of Shandong University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |