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

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

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.

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.

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.