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

August 31, 2021 updated by: Maimónides Biomedical Research Institute of Córdoba
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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Córdona
      • Córdoba, Córdona, Spain, 14004
        • Hospital Universitario Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEVACIZUMAB
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.
Drug: Bevacizumab
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.
Active Comparator: BEST AVAILABLE TREATMENT
Patients will receive best available treatment for COVID-19.
Drug: BAT
Patients will receive best available treatment for COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: After 28 days
Mortality
After 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2/FiO2
Time Frame: 6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Ratio calculation
6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Clinical improvement according to scale recommended by WHO for COVID19
Time Frame: 24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
Time Frame: From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
Time to improvement of oxygenation
Time Frame: From randomization until outcome event assessed up to 28 days.
Improvement shown during, at least, 48 hours.
From randomization until outcome event assessed up to 28 days.
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.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
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.
Time to absence of oxygen need to maintain a saturation equal or over 93%
From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Favorable radiological evaluation.
Time Frame: From randomization until first documented radiology improvement, assessed up to 28 days.
Dictated by 3 radiologists.
From randomization until first documented radiology improvement, assessed up to 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEVACOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

When study is published.

IPD Sharing Access Criteria

Send request to access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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