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TnFa in COVID-19


Title A Phase 2 Trial Of Infliximab In Coronavirus Disease 2019 (Covid-19)
Therapeutic Area Covid-19
Principal Investigator Paul Mathew, MD
Min Age 18 Years
Gender Any
Contact Neely Center for Clinical Cancer Research
617-636-3264
NCCCR@tuftsmedicalcenter.org

Overview

This study is a prospective, single center, phase 2 trial to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

Study Details

Inclusion Criteria

  • Hospitalized adult patients with pneumonia evidenced by chest X-ray or CT scan
  • Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending
  • Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2

Exclusion Criteria

  • Treatment with TnFα inhibitor in the past 30 days.
  • Known hypersensitivity to any TNFα inhibitor, murine proteins, or any component of the formulation
  • Active or latent Hepatitis B or active TB or history of incomplete treatment of TB

Study Requirements

Subjects will participate in the study for up to 28 days.