The aim of this research is to evaluate an innovative treatment, Bevacizumab, in patientssuffering from respiratory complications related to COVID-19. These complications,particularly difficulty breathing (dyspnea) and impaired lung function, are common insome individuals after infection. The study seeks to determine whether Bevacizumab canimprove breathing capacity by acting on vascular mechanisms that may be responsible forthese issues. A total of 21 patients with these persistent symptoms will be included inthe study, with close medical monitoring to assess both the effectiveness of thetreatment and its safety.This research aims to assess the effectiveness and safety of Bevacizumab, a medicationknown for its anti-angiogenic properties (which prevent the formation of new bloodvessels), in patients experiencing persistent respiratory problems after COVID-19infection. In other words, this research is based on the idea that inhibiting bloodvessel formation with Bevacizumab may improve clinical outcomes in patients with severeforms 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 thepredicted value) at least three months after their initial COVID-19 infection will beincluded. 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'sparticipation will last 7 months, which includes 2 months of treatment (five Bevacizumabinjections) followed by five additional months of medical follow-up.In this research project, we will be evaluating Bevacizumab, an experimental drug in thecontext 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 thisstudy, its use aims to improve lung function in patients suffering from persistentrespiratory complications after COVID-19 infection.Bevacizumab will be administered as an intravenous infusion. The infusion lasts between30 and 90 minutes. The dosage is 10 mg/kg every two weeks, for a total of five infusionsover a two-month period. Additional follow-up visits will be conducted one month and fivemonths after the end of treatment. Monitoring will include clinical examinations,laboratory tests, and lung function assessments.
Not Provided
Drug: Bevacizumab Injection
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
HEGP, clinical investigation center
Paris, France
HEGP, department of Physiology
Paris, France
Cléo Bourgeois
+33 1 56 09 56 38
cleo.bourgeois@aphp.fr
David Smadja, PhD, Study Director
Assistance Publique - Hôpitaux de Paris