COVID19 PneumoniaPhase 2CORIMMUNO-BEVANCT04344782
Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
A Phase 2 study testing Bevacizumab Injection in people with COVID19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19 Pneumonia
- 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
- 130 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 30 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Requiring more than 3L/min of oxygen
- WHO progression scale = 5 to 8
Who cannot join
- Patients in 9 WHO progression class
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Hypersensitivity to Bevacizumab or to any of their excipients.
- Pregnancy
- Active Cancer with undergoing treatment
- Oxygen patient requiring long-term oxygen before hospitalization
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- Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator.
- Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery.
- Hypersensitivity to the active substance or one of the excipients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units.
This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
- Conditions
- COVID19 Pneumonia
- Being tested
- Bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab InjectionDrug
Treatment includes the administration on day 1 (D1) of an infusion of Bevacizumab 7.5 mg / kg in 100 ml saline for all patients weighing 100 kg or more. In control arm, patient receives standard care.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab Injection |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of surviving patients without need for intubation for respiratory support
Measured: day 14
Secondary outcomes (11)
Saturation of Oxygen in the blood (SaO2)
value of a healthy individual occurs between 95 - 100
Measured: day 14
Arterial oxygen partial pressure (paO2)
value of a healthy individual occurs between 75-100 mmHg
Measured: day 14
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
Normal level should be >500 Index of severity of acute respiratory distress syndrome (ARDS) mild if 200-300 moderate if 100-200 severe if < 200
Measured: day 14
CT-scan score
based on a Likert scale with scores ranging from 1 to 5 (1-definitely no; 2-probably no; 3-equivocal; 4-probably yes; 5-definitely yes)
Measured: day 14
dyspnea
measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
Measured: day 28
overall survival
Measured: day 14 and 28
admissionn to the intensive care unit (ICU)
Measured: day 14 and day 28
incidence of mechanical ventilation
Measured: day 14 and day 28
hospital length of stay
Measured: day 28
incidence of adverse event
Measured: day 28
VEGF plasma concentration
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19 PneumoniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344782
- Sponsor's protocol ID
- APHP200389-7
- Acronym
- CORIMMUNO-BEVA
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
- ClinicalTrials.gov ID
- NCT04344782
- Acronym / sponsor ID
- CORIMMUNO-BEVA / APHP200389-7
- Conditions
- COVID19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 14 Apr 2020 (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.
Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.
This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units.
This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab Injection |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients Requiring more than 3L/min of oxygen
- WHO progression scale = 5 to 8
Key exclusion criteria (9 listed)
- Patients in 9 WHO progression class
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Hypersensitivity to Bevacizumab or to any of their excipients.
- Pregnancy
- Active Cancer with undergoing treatment
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 InjectionTreatment includes the administration on day 1 (D1) of an infusion of Bevacizumab 7.5 mg / kg in 100 ml saline for all patients weighing 100 kg or more. In control arm, patient receives standard care. | Drug | Bevacizumab |
Primary outcome
Proportion of surviving patients without need for intubation for respiratory support
Time frame: day 14
11 secondary outcomes
Saturation of Oxygen in the blood (SaO2)
Time frame: day 14
Arterial oxygen partial pressure (paO2)
Time frame: day 14
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
Time frame: day 14
CT-scan score
Time frame: day 14
dyspnea
Time frame: day 28
overall survival
Time frame: day 14 and 28
admissionn to the intensive care unit (ICU)
Time frame: day 14 and day 28
incidence of mechanical ventilation
Time frame: day 14 and day 28
hospital length of stay
Time frame: day 28
incidence of adverse event
Time frame: day 28
VEGF plasma concentration
Time frame: day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab Injection in people with COVID19 Pneumonia, run by Assistance Publique - Hôpitaux de Paris.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques Cadranel, MD PhD (1 56 01 66 73 ext. 33, jacques.cadranel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of surviving patients without need for intubation for respiratory support (time frame: day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2020.