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Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients (BEVACOR)

Primary Purpose

ARDS, Human, Coronavirus Infection

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Bevacizumab
BAT
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS, Human focused on measuring ARDS, SARS-CoV-2, Bevacizumab

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age equal or over 18 and under 90 years old.
  • Confirmed COVID-19 positive diagnostic through PCR.
  • Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
  • Patient has received anti-viral and anti-inflammatory therapy.

  • Present any of the following clinical-functional criteria:

    1. Respiratory distress: Tachypnea> 30 breaths / minute
    2. Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg
  • Signed informed consent, directly or delegated.

Exclusion Criteria:

  • Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
  • Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
  • Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
  • History of poorly controlled heart disease with a NYHA> 2.
  • History of thrombosis in the previous 6 months.
  • Signs of active bleeding.
  • Open wounds, gastrointestinal perforation.
  • Diagnosis of thrombophilic diseases or hemorrhagic diathesis.
  • Active viral hepatitis or HIV not properly treated.
  • Intolerance or allergy to bevacizumab or its components.
  • Pregnancy.

Sites / Locations

  • Hospital Universitario Reina Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BEVACIZUMAB

BEST AVAILABLE TREATMENT

Arm Description

Patients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.

Patients will receive best available treatment for COVID-19.

Outcomes

Primary Outcome Measures

Mortality
Mortality

Secondary Outcome Measures

PaO2/FiO2
Ratio calculation
Clinical improvement according to scale recommended by WHO for COVID19
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
Time to improvement of oxygenation
Improvement shown during, at least, 48 hours.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
Time to absence of oxygen need to maintain a saturation equal or over 93%
Time to absence of oxygen need to maintain a saturation equal or over 93%
Favorable radiological evaluation.
Dictated by 3 radiologists.

Full Information

First Posted
July 6, 2021
Last Updated
August 31, 2021
Sponsor
Maimónides Biomedical Research Institute of Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT04954014
Brief Title
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
Acronym
BEVACOR
Official Title
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of financing, lack of COVID19 patients in the ICU.
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
Detailed Description
The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS. As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human, Coronavirus Infection
Keywords
ARDS, SARS-CoV-2, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BEVACIZUMAB
Arm Type
Experimental
Arm Description
Patients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
Arm Title
BEST AVAILABLE TREATMENT
Arm Type
Active Comparator
Arm Description
Patients will receive best available treatment for COVID-19.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
Intervention Type
Drug
Intervention Name(s)
BAT
Intervention Description
Patients will receive best available treatment for COVID-19.
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality
Time Frame
After 28 days
Secondary Outcome Measure Information:
Title
PaO2/FiO2
Description
Ratio calculation
Time Frame
6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Title
Clinical improvement according to scale recommended by WHO for COVID19
Description
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
Time Frame
24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Title
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
Description
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
Time Frame
From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
Title
Time to improvement of oxygenation
Description
Improvement shown during, at least, 48 hours.
Time Frame
From randomization until outcome event assessed up to 28 days.
Title
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
Description
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
Time Frame
From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
Title
Time to absence of oxygen need to maintain a saturation equal or over 93%
Description
Time to absence of oxygen need to maintain a saturation equal or over 93%
Time Frame
From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Title
Favorable radiological evaluation.
Description
Dictated by 3 radiologists.
Time Frame
From randomization until first documented radiology improvement, assessed up to 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age equal or over 18 and under 90 years old. Confirmed COVID-19 positive diagnostic through PCR. Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate. Patient has received anti-viral and anti-inflammatory therapy. Present any of the following clinical-functional criteria: Respiratory distress: Tachypnea> 30 breaths / minute Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg Signed informed consent, directly or delegated. Exclusion Criteria: Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal) Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis. Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy. History of poorly controlled heart disease with a NYHA> 2. History of thrombosis in the previous 6 months. Signs of active bleeding. Open wounds, gastrointestinal perforation. Diagnosis of thrombophilic diseases or hemorrhagic diathesis. Active viral hepatitis or HIV not properly treated. Intolerance or allergy to bevacizumab or its components. Pregnancy.
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
State/Province
Córdona
ZIP/Postal Code
14004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
When study is published.
IPD Sharing Access Criteria
Send request to access.

Learn more about this trial

Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients

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