Dyspnea Caused by 2019-nCoVPhase 2BASECOVIDNCT07089719
Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)
A Phase 2 study testing Bevacizumab Injection in people with Dyspnea Caused by 2019-nCoV, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dyspnea Caused by 2019-nCoV
- What is being tested?
- Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2025to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
HEGP, clinical investigation center
Paris, 75015
Jean-Sebastien Hulot, PhD, +33 1 56 09 20 17, jean-sebastien.hulot@aphp.fr
Jean Sébastien Hulot, PhD
HEGP, department of Physiology
Paris, 75015
Sven Gunther, PhD, 0156095451 ext. +33, sven.gunther@aphp.fr
Sven Gunther, PhD
About this study
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.
Read more
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
- Being tested
- Bevacizumab Injection
- Keywords
- dyspnea caused by 2019-nCov, Covid-19, bevacizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the introduction of bevacizumab.
Secondary outcomes (7)
Proportion of patients with recovery of clinical symptoms
Modification of clinical evaluation and in particular the clinical symptom of dyspnea and fatigue or other related clinical parameters of long-COVID patients (mMRC Scale, Borg Scale, STOP-BANG Questionnaire, WHODAS 2.0, Epworth Sleepiness Scale, which assess fatigue severity in long-COVID patients).
Measured: 1, 2, 3 and 7 months after the initiation of Bevacizumab.
Proportion of patients with recovery of psychological, cognitive, and autonomic functions
Evaluation of psychological, cognitive, and autonomic functions. 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) and the Survey of Autonomic Symptoms.
Measured: 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
Modification of other respiratory function markers: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, total lung capacity (TLC), residual volume (RV), and 6-minutes walking distance test between baseline and follow-up.
Measured: 1, 2, 3 and 7-months after the initiation of Bevacizumab treatment.
Modification of DLCO
Difference of DLCO between baseline and follow-up.
Measured: 1 and 2 months after the initiation of Bevacizumab treatment.
Circulating angiogenic biomarkers levels
Difference of circulating angiogenic biomarkers levels between baseline and follow-up.
Measured: 1, 2, 3 and 7 months after the initiation of Bevacizumab treatment.
Number of side effects related to bevacizumab
Safety of bevacizumab in long-COVID patients regarding treatment side effects.
Measured: From bevacizumab treatment initiation to the end of the follow-up at 7 months.
Number of patients with hospitalization or medical consultation
Safety of bevacizumab in long-COVID patients regarding hospitalization or medical consultation.
Measured: From bevacizumab treatment initiation to the end of the follow-up at 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dyspnea Caused by 2019-nCoVStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- David Smadja, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089719
- Sponsor's protocol ID
- APHP241020
- Other IDs
- RECHMIE-23-0004, 2024-520308-24-00
- Acronym
- BASECOVID
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Publications
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.
PubMed 37526809
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab in Post-acute Sequelae of COVID-19 : Efficacy and Safety (Pilot Study)
- ClinicalTrials.gov ID
- NCT07089719
- Acronym / sponsor ID
- BASECOVID / APHP241020
- Conditions
- Dyspnea Caused by 2019-nCoV
- Keywords
- dyspnea caused by 2019-nCov, Covid-19, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, ANRS, Emerging Infectious Diseases
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab InjectionParticipants will receive Bevacizumab at a dose of 10mg/kg via intravenous infusion. They will receive a total of 5 injections, administered every two weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab InjectionParticipants 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 |
Primary outcome
Rate of patients with 10% increase of impaired DLCO
Time frame: 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.
7 secondary outcomes
Proportion of patients with recovery of clinical symptoms
Time frame: 1, 2, 3 and 7 months after the initiation of Bevacizumab.
Proportion of patients with recovery of psychological, cognitive, and autonomic functions
Time frame: 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
Time frame: 1, 2, 3 and 7-months after the initiation of Bevacizumab treatment.
Modification of DLCO
Time frame: 1 and 2 months after the initiation of Bevacizumab treatment.
Circulating angiogenic biomarkers levels
Time frame: 1, 2, 3 and 7 months after the initiation of Bevacizumab treatment.
Number of side effects related to bevacizumab
Time frame: From bevacizumab treatment initiation to the end of the follow-up at 7 months.
Number of patients with hospitalization or medical consultation
Time frame: From bevacizumab treatment initiation to the end of the follow-up at 7 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 37526809Philippe 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Related trials for Dyspnea Caused by 2019-nCoV
Active, not recruitingObservational study
Post Acute Sequelae of COVID-19
Covid19, Sars-CoV-2 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Smadja, PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab Injection in people with Dyspnea Caused by 2019-nCoV, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cléo Bourgeois (+33 1 56 09 56 38, cleo.bourgeois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with 10% increase of impaired DLCO (time frame: 3 months after the introduction of bevacizumab.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.