Pilot study of bevacizumab as a treatment for respiratory distress in patients with COVID-19

Pilot study of single-dose bevacizumab as a treatment for acute respiratory distress syndrome in patients with COVID-19

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001541-39-ES

Enrollment

Registered

2020-04-27

Start date

2020-04-24

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome in patients with COVID-19 MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Avastin Pharmaceutical Form: Solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 and 30 breaths / minute 5.b. Partial arterial oxygen pressure (PaO2) / Inspiration fraction (FiO2) = 300 mmHg 6. Signature of direct or delegated informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: 1. Severe liver dysfunction (Child Pugh = 3 or AST> 5 times normal) 2. Severe renal dysfunction with glomerular filtration 160 mmHg or TAd 2 5. History of thrombosis the previous 6 months 6. Signs of active bleeding 7. Open wounds, gastrointestinal perforation fractures 8. Diagnosis of thrombophilic diseases or bleeding diathesis 9. Active viral hepatitis or HIV not adequately treated 10. Intolerance or allergy to bevacizumab or its components 11. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the crude mortality rate at 28 days.;Secondary Objective: - To evaluate the improvement in the PaO2 / FiO2 ratio at 24 hours, at 72 hours, at 7 days, 14 days and 28 days. - To evaluate the improvement in the degree of dyspnea at 72 hours and at 7 days according to the Likert scale (-3 to +3). - To evaluate the improvement of the radiological findings by (simple radiology) at 72 hours and at 7 days. - To evaluate the improvement in transcutaneous O2 saturation at 24 hours, at 72 hours and at 7 days. - To evaluate the improvement in PaO2. - To measure the decrease in mortality (crude rate per month). - To evaluate the toxicity of the established strategy.;Primary end point(s): 1. Crude mortality at 28 days.;Timepoint(s) of evaluation of this end point: 28 days after the inclusion of the patient.	—

Measure

Time frame

Main Objective: - To evaluate the crude mortality rate at 28 days.;Secondary Objective: - To evaluate the improvement in the PaO2 / FiO2 ratio at 24 hours, at 72 hours, at 7 days, 14 days and 28 days. - To evaluate the improvement in the degree of dyspnea at 72 hours and at 7 days according to the Likert scale (-3 to +3). - To evaluate the improvement of the radiological findings by (simple radiology) at 72 hours and at 7 days. - To evaluate the improvement in transcutaneous O2 saturation at 24 hours, at 72 hours and at 7 days. - To evaluate the improvement in PaO2. - To measure the decrease in mortality (crude rate per month). - To evaluate the toxicity of the established strategy.;Primary end point(s): 1. Crude mortality at 28 days.;Timepoint(s) of evaluation of this end point: 28 days after the inclusion of the patient.

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Secondary

Measure	Time frame
Secondary end point(s): 1. PaO2 / FiO2 ratio: it will be measured the average of three evaluations of this ratio with a time interval of at least 6 hours, before and after administration of bevacizumab at 24 hours, at 72 hours, at 7 days, 14 days and 28 days. 2. Time to clinical improvement: time (in days) to improvement in the National Early Warning Score 2 (NEWS). It is defined as time in days from randomization to any of the following criteria: (i) improvement of two points on the 7-category scale or, (ii) discharge from the hospital. The criteria reached before are used. 3. Time (in days) until improvement in oxygenation for at least 48 hours: - Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with bevacizumab. - Time until the need for oxygen to maintain saturation in ambient air = 93%. - Favorable radiological evolution established by three radiologists. - Number of days in need of supplemental oxygen. - Average time in the duration of: - High flow nasal oxygen. - Noninvasive mechanical ventilation. - Invasive mechanical ventilation. 4. Proportion of patients requiring invasive mechanical ventilation. Security Variables 1. Incidence of adverse events related to medication and its administration. 2. Incidence in the appearance of serious bacterial, fungal or opportunistic infections. 3. Incidence of perforation of the gastrointestinal tract. 4. Mean white blood cell and neutrophil count. 5. Average hemoglobin levels. 6. Average platelet count. 7. Average levels of creatinemia. 8. Average bilirubin levels. 9. Average ALT and AST levels. 10. Development of HTA. 11. Hemorrhages. 12. Thromboembolic events.;Timepoint(s) of evaluation of this end point: At 24 hours, at 72 hours, at 7 days, 14 days and 28 days after the inclusion of the patient.	—

Measure

Time frame

Secondary end point(s): 1. PaO2 / FiO2 ratio: it will be measured the average of three evaluations of this ratio with a time interval of at least 6 hours, before and after administration of bevacizumab at 24 hours, at 72 hours, at 7 days, 14 days and 28 days. 2. Time to clinical improvement: time (in days) to improvement in the National Early Warning Score 2 (NEWS). It is defined as time in days from randomization to any of the following criteria: (i) improvement of two points on the 7-category scale or, (ii) discharge from the hospital. The criteria reached before are used. 3. Time (in days) until improvement in oxygenation for at least 48 hours: - Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with bevacizumab. - Time until the need for oxygen to maintain saturation in ambient air = 93%. - Favorable radiological evolution established by three radiologists. - Number of days in need of supplemental oxygen. - Average time in the duration of: - High flow nasal oxygen. - Noninvasive mechanical ventilation. - Invasive mechanical ventilation. 4. Proportion of patients requiring invasive mechanical ventilation. Security Variables 1. Incidence of adverse events related to medication and its administration. 2. Incidence in the appearance of serious bacterial, fungal or opportunistic infections. 3. Incidence of perforation of the gastrointestinal tract. 4. Mean white blood cell and neutrophil count. 5. Average hemoglobin levels. 6. Average platelet count. 7. Average levels of creatinemia. 8. Average bilirubin levels. 9. Average ALT and AST levels. 10. Development of HTA. 11. Hemorrhages. 12. Thromboembolic events.;Timepoint(s) of evaluation of this end point: At 24 hours, at 72 hours, at 7 days, 14 days and 28 days after the inclusion of the patient.

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Countries

Spain

Contacts

Public ContactAntonio Luque

Fundación para la Investigación Biomédica de Córdoba

uicec@imibic.org0034671596070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026