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

NCT04954014 | Terminated Phase 2

• 1 other identifier: BEVACOR
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human; Coronavirus Infection

Keywords

ARDS; SARS-CoV-2; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality

  After 28 days

Secondary Outcomes (7)

• PaO2/FiO2

  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

  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)

  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

  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.

  From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.

Study Arms (2)

BEVACIZUMAB

EXPERIMENTAL

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

BEST AVAILABLE TREATMENT

ACTIVE COMPARATOR

Patients will receive best available treatment for COVID-19.

Drug: BAT

Interventions

Bevacizumab DRUG

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.

BEVACIZUMAB

BAT DRUG

Patients will receive best available treatment for COVID-19.

BEST AVAILABLE TREATMENT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, Córdona, 14004, Spain

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 6, 2021
• First Posted: July 8, 2021
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: When study is published.
• Access Criteria: Send request to access.

Locations

ES (1)