ALXN1210-COV-305 [COVID-19]

• Research type

  Research Study

• Full title

  A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress

• IRAS ID

  283394

• Contact name

  Austin Kulasekararaj

• Contact email

  austin.kulasekararaj@nhs.net

• Sponsor organisation

  Alexion Pharmaceuticals, Inc.

• Eudract number

  2020-001497-30

• Clinicaltrials.gov Identifier

  NCT04369469

• Clinicaltrials.gov Identifier

  149271, IND Number

• Duration of Study in the UK

  0 years, 5 months, 18 days

• Research summary

  Research Summary
  The ALXN1210 COV 305 is a multicentre Phase 3, open label, randomised, controlled study designed to evaluate the safety and efficacy of intravenous (IV) ravulizumab + best supportive care (BSC), compared with BSC alone in patients with a confirmed diagnosis of SARS CoV 2 infection, and a clinical presentation consistent with COVID 19 severe pneumonia, Acute Lung Injury (ALI), or Acute Respiratory Distress Syndrome (ARDS).\n\nRavulizumab (ULTOMIRIS®), is a medication currently approved to treat complement-mediated diseases such as paroxysmal nocturnal haemoglobinuria in certain parts of the world. Complement-mediated diseases affect the immune system and its ability to fight bacteria or viruses and there is emerging scientific evidence supporting the role of complement in virally induced lung injury. Ravulizumab (ULTOMIRIS®) is not approved by health authorities for treating severe pneumonia, ALI or ARDS associated with COVID-19 infection. The purpose of this study is to determine if ULTOMIRIS may reduce injury associated with these conditions.\n\nThe study consists of a Screening Period of up to 3 days, a Primary Evaluation Period of 4 weeks, a final assessment at Day 29 or upon discharge, and a Follow up Period of 8 weeks. The 2 follow up visits will be conducted 4 weeks apart as a telephone call if the patient is discharged from the hospital or an in person visit if the patient is still hospitalised. \n\nEligible patients who meet all inclusion and no exclusion criteria will be randomised in a 2:1 ratio to receive:\n•\tGroup 1: Ravulizumab + Best Supportive Care (BSC)\n•\tGroup 2: BSC alone\n\nIt is anticipated that participants will be in the study for approximately 3 months.\nApproximately 20 study centres will be opened in the US and EU countries to enroll approximately 270 participants. In the UK it is expected that the study will take place in several sites and about 25-50 participants will be enrolled.\n

  Summary of Results
  Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  20/HRA/2068

• Date of REC Opinion

  7 May 2020

• REC opinion

  Further Information Favourable Opinion