Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort (CORIMMUNO-BEVA)

• ClinicalTrials.gov Identifier: NCT04344782
• Recruitment Status: Unknown
• First Posted: April 14, 2020
• Last Update Posted: April 17, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: April 9, 2020
• First Posted Date: April 14, 2020
• Last Update Posted Date: April 17, 2020
• Estimated Study Start Date: April 15, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 12, 2020): Proportion of surviving patients without need for intubation for respiratory support [ Time Frame: day 14 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 16, 2020)

• Saturation of Oxygen in the blood (SaO2) [ Time Frame: day 14 ]
  value of a healthy individual occurs between 95 - 100
• Arterial oxygen partial pressure (paO2) [ Time Frame: day 14 ]
  value of a healthy individual occurs between 75-100 mmHg
• Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2) [ Time Frame: day 14 ]
  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
• CT-scan score [ Time Frame: day 14 ]
  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)
• dyspnea [ Time Frame: day 28 ]
  measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
• 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 ]

Original Secondary Outcome Measures (submitted: April 12, 2020)

• Saturation of Oxygen in the blood (SaO2) [ Time Frame: day 14 ]
  value of a healthy individual occurs between 95 - 100
• Arterial oxygen partial pressure (paO2) [ Time Frame: day 14 ]
  value of a healthy individual occurs between 75-100 mmHg
• Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2) [ Time Frame: day 14 ]
  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
• CT-scan score [ Time Frame: day 14 ]
• dyspnea [ Time Frame: day 28 ]
  measured on an visual analog scale (VAS), ranging from 0 (no dyspnea) to 10 (major dyspnea)
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
• Official Title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial

Brief 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: COVID19 Pneumonia

Intervention

Drug: Bevacizumab Injection

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 Arms

• Experimental: Bevacizumab
  Intervention: Drug: Bevacizumab Injection
• No Intervention: Standard of Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 12, 2020): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients Requiring more than 3L/min of oxygen
• WHO progression scale = 5 to 8

Exclusion Criteria:

• 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
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04344782
• Other Study ID Numbers: APHP200389-7
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: April 2020