APN01-01-COVID19 [COVID-19]
Research type
Research Study
Full title
Recombinant human angiotensin-converting enzyme 2 (rhACE2) as a treat-ment for patients with COVID-19
IRAS ID
283763
Contact name
Sonja Höller
Contact email
Sponsor organisation
APEIRON Biologics AG
Eudract number
2020-001172-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
na, na
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
Aim of the study is to evaluate the clinical efficacy and safety of APN01 in patients\nwith severe COVID-19, defined as those with hypoxemia and\ntachypnea. \nThe study is a parallel-group, randomized, double blind, placebo-controlled\nstudy on top of best standard of care.\nThe study will comprise two treatment groups as follows:\n Group A (active): APN01 (5mg/ml, 4 ml/vial)\n Group B (placebo control): sterile, 0.9% sodium chloride\nEligible patients will be centrally allocated using a dynamic randomization\n(1:1) at baseline (day 1) to Group A or B to receive the treatment or\nplacebo. Dynamic randomization factors will be age in years (continuous),\npresence of at least one relevant co-morbid condition (hypertension,\ndiabetes, coronary artery disease) and center. Investigators and\npatients will be blinded to the treatment administered.\nAfter screening at day -1 and randomization at day 1, patients will be\ntreated with APN01 or Placebo intravenously twice daily (BID) every 12\nhours ±1 hour over 3 to 30 minutes (morning and the evening) for 14\ndoses (until day 7).\nFollow up visits will be done at a daily basis for the first seven days and\nthen on day 10, 14 and 28 to asses efficacy and safety. The study assessments\nwill be performed according to the study schedule.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0163
Date of REC Opinion
5 May 2020
REC opinion
Favourable Opinion