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Asunercept in Patients With Severe COVID-19 (ASUNCTIS)

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ClinicalTrials.gov Identifier: NCT04535674
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Apogenix AG

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date August 4, 2021
Actual Study Start Date  ICMJE October 9, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Asunercept in Patients With Severe COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE
  • COVID-19 Induced Pneumonia
  • Covid19
Intervention  ICMJE Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carola Straub +49 6221 58608 ext 72 carola.straub@apogenix.com
Listed Location Countries  ICMJE Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04535674
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Apogenix AG
Study Sponsor  ICMJE Apogenix AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pilar Ruiz-Seco, PhD-MD Hospital Universitario Infanta Sofía, Madrid
PRS Account Apogenix AG
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP