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

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Study ID
NCT04954014
Phase
PHASE2
Status
Terminated

Conditions

  • ARDS, Human
  • Coronavirus Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
  • BAT — DRUG
    Patients will receive best available treatment for COVID-19.

Study Details

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.

Key Dates

First listed
Jul 8, 2021
Start date
Sep 1, 2020
Status verified
Aug 2021
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BEVACIZUMAB
    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.
  • Active Comparator: BEST AVAILABLE TREATMENT
    Patients will receive best available treatment for COVID-19.

Primary Outcome Measure

Mortality [ Time Frame: After 28 days ]

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