Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)

NCT07089719 | Not Yet Recruiting Phase 2

• 3 other identifiers: APHP241020RECHMIE-23-00042024-520308-24-00
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dyspnea Caused by 2019-nCoV

Keywords

dyspnea caused by 2019-nCov; Covid-19; bevacizumab

Outcome Measures

Primary Outcomes (1)

• Rate of patients with 10% increase of impaired DLCO

  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.

  3 months after the introduction of bevacizumab.

Secondary Outcomes (7)

• 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.

Study Arms (1)

Bevacizumab

EXPERIMENTAL

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.

Drug: Bevacizumab Injection

Interventions

Bevacizumab Injection DRUG

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.

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years, under 90 years
• Social security affiliation
• Good understanding of the French language
• Written informed consent
• 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

You may not qualify if:

• 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
• 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
• Patient unable or unwilling to comply with the follow up schedule (at the investigator's discretion)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (2)

HEGP, clinical investigation center

Paris, 75015, France

Location

HEGP, department of Physiology

Paris, 75015, France

Location

Related Publications (1)

• Philippe A, Gunther S, Rancic J, Cavagna P, Renaud B, Gendron N, Mousseaux E, Hua-Huy T, Reverdito G, Planquette B, Sanchez O, Gaussem P, Salmon D, Diehl JL, Smadja DM. VEGF-A plasma levels are associated with impaired DLCO and radiological sequelae in long COVID patients. Angiogenesis. 2024 Feb;27(1):51-66. doi: 10.1007/s10456-023-09890-9. Epub 2023 Aug 1.

  PMID: 37526809 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David Smadja, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Cléo Bourgeois

CONTACT

+33 1 56 09 56 38; cleo.bourgeois@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (2)