BEVACIZUMAB for Post-acute sequelae of COVID-19 (Long COVID)|Persistent dyspnea

Inclusion criteria

• {"criterion_text":"- 1-\tPatients over 18 years ≤70 years\n- 2-\tSocial security affiliation\n- 3-\tGood understanding of the French language\n- 4-\tWritten informed consent\n- 5-\tDocumented COVID-19 infection (PCR or CT scan) more than 3 months before inclusion\n- 6-\tLong COVID suspicion with dyspnea (mMRC≥2 at inclusion)\n- 7-\tDLCO<75% of predicted value less than 3 months old on the day of screening or to be obtained before Day 1 if older than 3 months."}

Exclusion criteria

• {"criterion_text":"- 1-\tAcute COVID-19 infection\n- 22-\tPregnant or breastfeeding women\n- 23-\tVulnerable populations (patient under guardianship, curatorship, deprived of liberty)\n- 2-\tLung scintigraphy and thoracic CT angiography evaluation to rule out pulmonary embolism\n- 24-\tPatient on AME (state medical aid)\n- 3-\tWomen of childbearing potential\n- 4-\tMyocardial infarction or stroke\n- 5-\tUncontrolled hypertension (>140/90 at inclusion in the study)\n- 6-\tProteinuria/creatinuria ratio > 50mg/mmol at baseline\n- 8-\tHistory of malignant hypertension\n- 10 -\tPrevious osteonecrosis\n- 14-\tActive cancer\n- 11-\tHistory of Aneurysms and artery dissections\n- 7-\tDFG<30 ml/min\n- 9-\tDiagnosis of other pulmonary diseases known to impair DLCO (such as chronic obstructive pulmonary disease [COPD], idiopathic pulmonary fibrosis, interstitial lung diseases unrelated to COVID-19, or other significant chronic pulmonary conditions)\n- 12-\tHistory of hemoptysis of any grade\n- 13-\tHistory of congestive heart failure (NYHA class II-IV)\n- 15-\tKnown hypersensitivity to bevacizumab or any ingredient in its formulation, including non-medicinal ingredients, or a component of the container\n- 16-\tHypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanized antibodies.\n- 17-\tHistory of Radiotherapy\n- 18-\tHistory of bisphosphonates treatment\n- 19-\tSurgery in 28 days before inclusion\n- 20-\tParticipation in another interventional study or being in the exclusion period at the end of a previous study\n- 21-\tPatient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is defined as the rate of patients with 10% increase of impaired DLCO within the 3 months after the introduction of bevacizumab.","definition_or_measurement_approach":"Rate of patients achieving a 10% increase in DLCO at 3 months after the first bevacizumab injection; DLCO measured by pulmonary function testing (baseline and at 3 months)."}

Secondary endpoints

• {"endpoint_text":"- 1-\tDescription of clinical symptoms at 1, 2, 3 and 7 months after the initiation of bevacizumab treatment in particular mMRC Scale, Borg Scale, STOP-BANG Questionnaire, WHODAS 2.0, Epworth Sleepiness Scale, which assess fatigue severity in long-COVID patients.","definition_or_measurement_approach":"Clinical symptom scales and questionnaires (mMRC, Borg, STOP-BANG, WHODAS 2.0, Epworth) assessed at 1, 2, 3 and 7 months."}
• {"endpoint_text":"- 2-\tDescription of psychological, cognitive, and autonomic functions at 3 and 7 months after the initiation of Bevacizumab treatment. In particular, additional assessments will be conducted to evaluate psychological, cognitive, and autonomic functions with the Nijmegen Questionnaire, the Hospital Anxiety and Depression Scale, the Montreal Cognitive Assessment, the self-reported Ricci-Gagnon Physical Activity Questionnaire, the Somatic Symptom Disorder Scale-12 (SSD-12) an","definition_or_measurement_approach":"Psychological, cognitive and autonomic function assessments (Nijmegen Questionnaire, HADS, MoCA, Ricci-Gagnon, SSD-12, etc.) at 3 and 7 months."}
• {"endpoint_text":"- 3-\tDescription of other parameter than DLCO explored by Pulmonary Function Test evaluated at 1, 2, 3 and 7 months after the initiation of Bevacizumab treatment. Difference of FEV1, FVC, FEV1/FVC ratio, TLC, RV and 6 minute walking distance between baseline and 1, 2, 3 and 7 months and the difference of DLCO between baseline and 1and 2 months.","definition_or_measurement_approach":"Pulmonary function test measures (FEV1, FVC, FEV1/FVC, TLC, RV) and 6-minute walk distance at baseline and 1, 2, 3 and 7 months; DLCO differences also evaluated at baseline vs 1 and 2 months."}
• {"endpoint_text":"- 4-\tDifference of circulating angiogenic biomarkers levels between baseline and 1, 2, 3 and 7 months after the initiation of Bevacizumab treatment.","definition_or_measurement_approach":"Change in circulating angiogenic biomarker levels from baseline at 1, 2, 3 and 7 months."}
• {"endpoint_text":"- 5-\tNumber of side effects related to bevacizumab and proportion of patients with hospitalization or medical consultation during the 7 months after the start of the treatment.","definition_or_measurement_approach":"Safety: count of adverse events related to bevacizumab and proportion of patients with hospitalization or medical consultations during 7-month follow-up."}

France

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

24-10-2025

Processing Time Days

16

Number Of Sites

1

Number Of Participants

21

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France