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

Phase 1

• Conditions: Acute respiratory distress syndrome in patients with COVID-19; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001541-39-ES
• Lead Sponsor: Fundación para la Investigación Biomédica de Córdoba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Age = 18 and <90 years
2. Diagnosis confirmed by COVID-19 PCR
3. Radiological image compatible with bilateral non-cardiogenic pleuropulmonary exudate
4. Having received antiviral and anti-inflammatory therapy according to the protocol of the Reina Sofía University Hospital in Córdoba
5. Present any of the following clinical-functional criteria:
5.a. Respiratory distress: Tachypnea> 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

1. Severe liver dysfunction (Child Pugh = 3 or AST> 5 times normal)
2. Severe renal dysfunction with glomerular filtration <30 mL / minute or in treatment with hemodialysis or peritoneal dialysis)
3. Poorly controlled arterial hypertension (TAs> 160 mmHg or TAd <100 mmHg) or having a previous history of hypertensive crisis or hypertensive encephalopathy
4. History of poorly controlled heart disease with a NYHA> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified