VIR-7831 for the early treatment of COVID-19 in outpatients

• Research type

  Research Study

• Full title

  A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody VIR-7831 for the early treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized patients

• IRAS ID

  286558

• Contact name

  Damien McNally

• Contact email

  damienmcnally@doctors.org.uk

• Sponsor organisation

  Vir Biotechnology, Inc.

• Eudract number

  2020-002871-36

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT04545060

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 5 months, 23 days

• Research summary

  Short title: VIR-7831 for the early treatment of COVID-19 in non-hospitalized patients

  Coronavirus (SARS-CoV-2) infection, the virus that causes COVID-19 has spread throughout the world. COVID-19 affects the lungs and airways. Common symptoms include fever, fatigue, or dry cough. People with severe COVID-19 may have shortness of breath, damage in their lung tissues, increased inflammation, and increased abnormal clotting in the blood vessels.

  There is an urgent need for effective treatment throughout the course of the illness. To date, there are no approved treatments for mild/moderate COVID-19.
  Vir Biotechnology, Inc. the study sponsor with the support of GlaxoSmithKline are running a first in human study of an investigational (experimental) medicine called VIR-7831. VIR-7831 is an antibody. Antibodies are proteins our bodies make to help fight infections. VIR-7831 has been modified to last longer in humans and may or may not improve the body’s ability to fight off coronavirus.

  This study will compare VIR-7831 with a placebo (dummy drug). Participants will have a 50% chance of being given VIR-7831 or placebo.

  This research study is being done to learn more about COVID-19. This study will investigate if VIR-7831 is safe and how well VIR-7831 works to treat people with COVID-19.

  The study has two parts. The first part includes 20 participants in the United States. The second part of the study will include about 1340 participants diagnosed with COVID-19 at about 100 sites around the world including but not limited to North America, South America, and Europe, including the United Kingdom. The study will be about 24 weeks long, or 6 months, from the time participants receive study drug.
  Study procedures include: medical history; physical examination; height and weight; recording of the heart; blood pressure; heart rate; breathing rate; oxygen levels and temperature; nose and throat swabs; blood samples, urine samples; and questionnaires.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  20/HRA/5337

• Date of REC Opinion

  9 Nov 2020

• REC opinion

  Unfavourable Opinion