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

• Status: Terminated
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Treatments: Bevacizumab

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:

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.