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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Terminated; Phase 2

Conditions: ARDS, Human; Coronavirus Infection

Treatments: Drug: Bevacizumab; Drug: BAT

Study type: Interventional

Funder types: Other

Identifiers

NCT04954014

BEVACOR

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

BEVACIZUMAB

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab

BEST AVAILABLE TREATMENT

Active Comparator group

Description:

Patients will receive best available treatment for COVID-19.

Treatment:

Drug: BAT