Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT07089719
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Dyspnea Caused by 2019-nCoV
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab Injection — DRUGParticipants will receive Bevacizumab at a dose of 10mg/kg via intravenous infusion. They will receive a total of 5 injections, administered every two weeks.
Study Details
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.
Key Dates
- First listed
- Jul 28, 2025
- Start date
- Oct 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Jan 1, 2028
- Completion
- May 1, 2028
Study Design
- Enrollment
- 21 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BevacizumabParticipants will receive Bevacizumab at a dose of 10mg/kg via intravenous infusion. They will receive a total of 5 injections, administered every two weeks.
Primary Outcome Measure
Rate of patients with 10% increase of impaired DLCO [ Time Frame: 3 months after the introduction of bevacizumab. ]
Central Contacts
- Cléo Bourgeois+33 1 56 09 56 38