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Asunercept in Patients With Severe COVID-19 (ASUNCTIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535674
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Apogenix AG

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.

Condition or disease Intervention/treatment Phase
COVID-19 Induced Pneumonia Covid19 Biological: Asunercept Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Official Title: A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
No Intervention: Standard of Care
Experimental: Standard of Care + Asunercept 25 mg Biological: Asunercept
Asuncercept (APG101) will be administered once per week as an i.v. infusion

Experimental: Standard of Care + Asunercept 100 mg Biological: Asunercept
Asuncercept (APG101) will be administered once per week as an i.v. infusion

Experimental: Standard of Care + Asunercept 400 mg Biological: Asunercept
Asuncercept (APG101) will be administered once per week as an i.v. infusion




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. Oxygenation [ Time Frame: Day 1-29 ]
    Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial

  3. Ventilation [ Time Frame: Day 1-29 ]
    Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial

  4. Hospitalisation - Length [ Time Frame: Day 1-29 ]
    Duration of hospitalisation Length of ICU stay (in days)

  5. Hospitalisation - Proportion on ICU [ Time Frame: Day 1-29 ]
    Proportion of patients admitted to ICU

  6. Mortality [ Time Frame: Day 1-29 ]
    15-day, 29-day all-cause mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laboratory confirmed infection with SARS-CoV-2 (ideally but not necessarily ≤72 hours before randomisation) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535674


Contacts
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Contact: Carola Straub +49 6221 58608 ext 72 carola.straub@apogenix.com

Locations
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Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation Not yet recruiting
Krasnodar, Russian Federation
Contact: Igor Zabolotskikh         
State Budgetary Healthcare Institution "Scientific Research Institute - Regional clinical hospital No. 1 n.a. professor S.V. Ochapovsky" of the Ministry of Healthcare of Krasnodar Krai Not yet recruiting
Krasnodar, Russian Federation
Contact: Zoya Tatarintseva         
State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod" Recruiting
Nizhny Novgorod, Russian Federation
Contact: Elena Tikhomolova         
Saint Petersburg state budgetary healthcare institution "Botkin clinical infectious diseases hospital" Not yet recruiting
Saint Petersburg, Russian Federation
Contact: Denis Gusev         
Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr" Recruiting
Saint Petersburg, Russian Federation
Contact: Igor Ivanov         
Saint Petersburg State Budgetary Healthcare Institution "Mariinskaya City hospital" Not yet recruiting
Saint Petersburg, Russian Federation
Contact: Natalya Gonchar         
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation Not yet recruiting
Ufa, Russian Federation
Contact: Bulat Bakirov         
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation Not yet recruiting
Ufa, Russian Federation
Contact: Damir Valishin         
Spain
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda, Spain
Contact: Alejandro Callejas Díaz         
Hospital Universitario Infanta Sofia Recruiting
San Sebastián De Los Reyes, Spain
Contact: Ines Suarez Garcia         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Jose Ramon Pano Pardo         
Sponsors and Collaborators
Apogenix AG
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Responsible Party: Apogenix AG
ClinicalTrials.gov Identifier: NCT04535674    
Other Study ID Numbers: APG101_CD_017
2020-001887-27 ( EudraCT Number )
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections