Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Rate of patients with 10% increase of impaired DLCO
研究概览
简要总结
The aim of this research is to evaluate an innovative treatment, Bevacizumab, in patients suffering from respiratory complications related to COVID-19. These complications, particularly difficulty breathing (dyspnea) and impaired lung function, are common in some individuals after infection. The study seeks to determine whether Bevacizumab can improve breathing capacity by acting on vascular mechanisms that may be responsible for these issues. A total of 21 patients with these persistent symptoms will be included in the study, with close medical monitoring to assess both the effectiveness of the treatment and its safety.
This research aims to assess the effectiveness and safety of Bevacizumab, a medication known for its anti-angiogenic properties (which prevent the formation of new blood vessels), in patients experiencing persistent respiratory problems after COVID-19 infection. In other words, this research is based on the idea that inhibiting blood vessel formation with Bevacizumab may improve clinical outcomes in patients with severe forms of COVID-19 by reducing vascular complications associated with the infection.
To answer this research question, 21 individuals with persistent respiratory symptoms (significant dyspnea) and reduced lung diffusing capacity (DLCO less than 75% of the predicted value) at least three months after their initial COVID-19 infection will be included. The study is being conducted at Hôpital Européen Georges Pompidou, in Paris.
The total expected duration of the research is 31 months, and each patient's participation will last 7 months, which includes 2 months of treatment (five Bevacizumab injections) followed by five additional months of medical follow-up.
In this research project, we will be evaluating Bevacizumab, an experimental drug in the context of Long COVID. Bevacizumab is a monoclonal antibody used to inhibit angiogenesis (the abnormal formation of new blood vessels). While commonly used in oncology, in this study, its use aims to improve lung function in patients suffering from persistent respiratory complications after COVID-19 infection.
Bevacizumab will be administered as an intravenous infusion. The infusion lasts between 30 and 90 minutes. The dosage is 10 mg/kg every two weeks, for a total of five infusions over a two-month period. Additional follow-up visits will be conducted one month and five months after the end of treatment. Monitoring will include clinical examinations, laboratory tests, and lung function assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years, under 90 years
- •Social security affiliation
- •Good understanding of the French language
- •Written informed consent
- •DOcumented COVID-19 infection (PCR or CT-scan) more than 3 months before inclusion
- •Long COVID suspicion with dyspnea (mMRC > 2 at inclusion)
- •DLCO < 75% of predicted value less than 3 months old on the day of screening or to be obtained before Day 1 older than 3 months
排除标准
- •Acute COVID-19 infection
- •Lung scintigraphy and thoracic CT angiography evaluation to rule out pulmonary embolism less than 3 months old on the day of screening or to be obtained before Day 1 if older than 3 months to exclude Sequelae of pulmonary embolism or lung emphysema in the setting of COPD
- •Women of childbearing potential
- •Myocardial infarction or stroke less than 3 months before screening
- •Uncontrolled hypertension (> 140/90 at inclusion in the study)
- •Proteinuria/creatinuria ratio > 1 g/mmol at baseline DFG < 30 ml/min
- •History of malignant hypertension
- •Previous osteonecrosis
- •History of Aneurysm and artery dissections
- •Active cancer
- •Known hypersensitivity to bevacizumab or any ingredient in its formulation, including non-medicinal ingredients, or a component of the container
- •Hypersensitivity to Chinese Hamster Ovary (CHO) cell product or other recombinant human or humanized antibodies
- •History of radiotherapy
- •History of bisphosphonates treatment
- •Surgery in 28 days before inclusion
- •Participation in another interventional study or being in the exclusion period at the end of a previous study
- •Patient unable or unwilling to comply with the follow up schedule (at the investigator's discretion)
- •Pregnant or breastfeeding women
- •Vulnerable populations (patient under gardianship, curatorship, deprived of liberty)
- •Patient on AME (State medical aid)
研究组 & 干预措施
Bevacizumab
Participants will receive Bevacizumab at a dose of 10mg/kg via intravenous infusion. They will receive a total of 5 injections, administered every two weeks.
干预措施: Bevacizumab Injection (Drug)
结局指标
主要结局
Rate of patients with 10% increase of impaired DLCO
时间窗: 3 months after the introduction of bevacizumab.
Assess efficacy of bevacizumab injection in long COVID patients with impaired DLCO (\<75% of predicted value). The positive criteria will be a 10% increase in DLCO at three months after the introduction of bevacizumab.
次要结局
- Proportion of patients with recovery of clinical symptoms(1, 2, 3 and 7 months after the initiation of Bevacizumab.)
- Proportion of patients with recovery of psychological, cognitive, and autonomic functions(3 and 7 months after the initiation of Bevacizumab treatment.)
- Proportion of patients with improvement of other parameter than DLCO explored by Pulmonary Function Test(1, 2, 3 and 7-months after the initiation of Bevacizumab treatment.)
- Modification of DLCO(1 and 2 months after the initiation of Bevacizumab treatment.)
- Circulating angiogenic biomarkers levels(1, 2, 3 and 7 months after the initiation of Bevacizumab treatment.)
- Number of side effects related to bevacizumab(From bevacizumab treatment initiation to the end of the follow-up at 7 months.)
- Number of patients with hospitalization or medical consultation(From bevacizumab treatment initiation to the end of the follow-up at 7 months.)