BIO101 in severe stage COVID-19 pneumonia [COVID-19]

• Research type

  Research Study

• Full title

  Adaptive design phase 2 to 3, randomised, double- blind, multicentre, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalised patients with COVID-19 pneumonia (severe stage)

• IRAS ID

  286440

• Contact name

  Tony Whitehouse

• Contact email

  Tony.Whitehouse@uhb.nhs.uk

• Sponsor organisation

  Biophytis S.A.

• Eudract number

  2020-001498-63

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  A study to evaluate the safety and effectiveness of BIO101 in preventing respiratory deterioration in participants hospitalised with severe grade Covid-19 pneumonia caused by SARS coronavirus 2 (SARS-CoV-2).

  SARS-CoV-2 can cause lung damage by disrupting the renin angiotensin system (RAS) which has a key role in regulating respiratory function. BIO101 activates a protein, the MAS receptor, a key component of the protective arm of the RAS and has been shown to restore respiratory function in pre-clinical models.

  The overall study goal is to determine whether BIO101 treatment (350 mg bid for up to 28 days) reduces the risk of respiratory failure and death in participants with pneumonia associated with Covid-19 infection.

  The study is in two parts and employs an adaptive design to allow modifications to key components while data are being analysed.
  • Part 1 is designed to assess whether BIO101 might have sufficient benefit in this participant group to fully investigate and establish its efficacy and safety in Part 2.
  • Part 2 has two stages. The first stage will review data from Part 1 to inform the sample size of the remainder of the study i.e. the second stage of Part 2.

  A maximum of 465 participants will be included worldwide in hospitals in the USA and in Europe.

  The study will not exceed 88 days per participant and consists of four periods:
  • Screening: Day -1 to 0
  • Baseline: Day 0
  • Treatment: Days 1-28 days
  • Follow-up: Day 14 and Day 60 after treatment ends

  Efficacy is assessed by record of events, status scales and biomarkers to include viral load (nasal/nasopharyngeal swab) and those related to the RAS / MAS pathways together with inflammatory and muscle specific markers.

  Safety is assessed by physical examination (including vital signs), safety labs (including urine pregnancy test and testicular biomarkers) and safety reporting.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  20/HRA/3525

• Date of REC Opinion

  1 Oct 2020

• REC opinion

  Further Information Favourable Opinion