Asunercept in Patients With Severe COVID-19 (ASUNCTIS)

• ClinicalTrials.gov Identifier: NCT04535674
• Recruitment Status: Completed
• First Posted: September 2, 2020
• Last Update Posted: January 14, 2022
• Sponsor: Apogenix AG
• Information provided by (Responsible Party): Apogenix AG

Tracking Information

• First Submitted Date: August 31, 2020
• First Posted Date: September 2, 2020
• Last Update Posted Date: January 14, 2022
• Actual Study Start Date: October 9, 2020
• Actual Primary Completion Date: October 29, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2020)

Time to sustained improvement of one category (i.e. two consecutive days) from randomisation [ Time Frame: Day 1-29 ]

The primary endpoint is time to clinical improvement which is defined as time from randomisation to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomisation measured on a nine-category ordinal scale (proposed by WHO).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 21, 2021)

• Efficacy according to the National Early Warning Score (NEWS) [ Time Frame: Day 1-29 ]
  Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline
• Oxygenation [ Time Frame: Day 1-29 ]
  Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
• Ventilation [ Time Frame: Day 1-29 ]
  Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial
• Hospitalisation - Length [ Time Frame: Day 1-29 ]
  Duration of hospitalisation Length of ICU stay (in days)
• Hospitalisation - Proportion on ICU [ Time Frame: Day 1-29 ]
  Proportion of patients admitted to ICU
• Mortality [ Time Frame: Up to 90 days ]
  15-day, 29-day, 60-day and 90-day all-cause mortality

Original Secondary Outcome Measures (submitted: September 1, 2020)

• Efficacy according to the National Early Warning Score (NEWS) [ Time Frame: Day 1-29 ]
  Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline
• Oxygenation [ Time Frame: Day 1-29 ]
  Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
• Ventilation [ Time Frame: Day 1-29 ]
  Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial
• Hospitalisation - Length [ Time Frame: Day 1-29 ]
  Duration of hospitalisation Length of ICU stay (in days)
• Hospitalisation - Proportion on ICU [ Time Frame: Day 1-29 ]
  Proportion of patients admitted to ICU
• Mortality [ Time Frame: Day 1-29 ]
  15-day, 29-day all-cause mortality

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Asunercept in Patients With Severe COVID-19
• Official Title: A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease
• Brief Summary: This is an open-label, randomized, phase II study with the main objective to investigate the effectiveness and safety of an investigational drug (APG101; International Nonproprietary Name: asunercept) in patients with severe COVID-19 disease. The study aims to decrease overall and SARS-CoV-2 associated pneumonia mortality in patients with COVID-19 as well as to decrease the percentage of patients admitted to Intensive Care Unit (ICU), decrease the need to supply oxygen to patients, reduce the number of days patients are hospitalized in ICU and/or on the ward, decrease the number of days required to obtain a negative result in the PCR (Polymerase Chain Reaction, a laboratory technique that allows the amplification of small fragments of DNA to detect the presence of the virus) test for COVID-19 and decrease the levels of markers that indicate pneumonia.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Asunercept/APG101 will be tested in three parallel intervention arms and compared with Standard of Care (SoC). The study will compare treatment efficacy of SoC to that of weekly intravenous infusions of Asunercept at three different doses. Patients will be randomised into four groups.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• COVID-19 Induced Pneumonia
• Covid19

Intervention

Biological: Asunercept

Asunercept (APG101) will be administered once per week as an i.v. infusion

Study Arms

• No Intervention: Standard of Care
• Experimental: Standard of Care + Asunercept 25 mg
  Intervention: Biological: Asunercept
• Experimental: Standard of Care + Asunercept 100 mg
  Intervention: Biological: Asunercept
• Experimental: Standard of Care + Asunercept 400 mg
  Intervention: Biological: Asunercept

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 13, 2022): 438
• Original Estimated Enrollment (submitted: September 1, 2020): 400
• Actual Study Completion Date: December 21, 2021
• Actual Primary Completion Date: October 29, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of SARS-CoV-2 infection
• Hospitalisation due to COVID-19
• Informed Consent obtained, the patient understands and agrees to comply with the planned study procedures. If a potential patient is unconscious, the Patient Information Sheet with the Informed Consent Form can be signed by the legal representative, if he/she accompanies the patient. It can be signed by a Concilium consisting of doctors (2), investigator and an independent witness in case the legal representative is not available.
• ≥18 years of age
• Willingness to perform effective measures of contraception during the study.
• Signs of respiratory deterioration such as oxygen saturation ≤94% when breathing ambient air or >3% drop in oxygen saturation in case of chronic obstructive lung disease OR need for oxygen supplementation to achieve satisfactory blood oxygen saturation (sPO2>90% at room air) as well as the need for non-invasive ventilation, high-flow oxygen devices or mechanical ventilation or radiological or clinical signs of pneumonia.

Exclusion Criteria:

• Moribund, or estimated life expectancy <1 month (e.g., terminal cancer, etc.)
• Patient does not qualify for intensive care, based on local triage criteria
• Pregnancy or breast feeding
• Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)
• Anticipated discharge from hospital within 48 hours
• Other potent anti-inflammatory treatment, e.g. TNF- blocking therapies
• Mechanical ventilation for >48 hours
• Known active HIV or viral hepatitis infection
• Known active tuberculosis
• Known hereditary fructose intolerance

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation, Spain

Administrative Information

• NCT Number: NCT04535674
• Other Study ID Numbers: APG101_CD_017; 2020-001887-27 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Apogenix AG
• Study Sponsor: Apogenix AG
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pilar Ruiz-Seco, PhD-MD; Hospital Universitario Infanta Sofía, Madrid

• PRS Account: Apogenix AG
• Verification Date: July 2021