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Asunercept in Patients With Severe COVID-19 (ASUNCTIS)

Primary Purpose

COVID-19 Induced Pneumonia, Covid19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Asunercept
Sponsored by
Apogenix AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Induced Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov
  • Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases
  • Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
  • 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
  • State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"
  • Ryazan State Medical University n.a. academician I.P. Pavlov
  • Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Paz
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario Infanta Sofia
  • Hospital Clínico Universitario Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard of Care

Standard of Care + Asunercept 25 mg

Standard of Care + Asunercept 100 mg

Standard of Care + Asunercept 400 mg

Arm Description

Outcomes

Primary Outcome Measures

Time to sustained improvement of one category (i.e. two consecutive days) from randomisation
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

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

Full Information

First Posted
August 31, 2020
Last Updated
January 13, 2022
Sponsor
Apogenix AG
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1. Study Identification

Unique Protocol Identification Number
NCT04535674
Brief Title
Asunercept in Patients With Severe COVID-19
Acronym
ASUNCTIS
Official Title
A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apogenix AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Induced Pneumonia, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Title
Standard of Care + Asunercept 25 mg
Arm Type
Experimental
Arm Title
Standard of Care + Asunercept 100 mg
Arm Type
Experimental
Arm Title
Standard of Care + Asunercept 400 mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Asunercept
Intervention Description
Asunercept (APG101) will be administered once per week as an i.v. infusion
Primary Outcome Measure Information:
Title
Time to sustained improvement of one category (i.e. two consecutive days) from randomisation
Description
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).
Time Frame
Day 1-29
Secondary Outcome Measure Information:
Title
Efficacy according to the National Early Warning Score (NEWS)
Description
Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline
Time Frame
Day 1-29
Title
Oxygenation
Description
Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
Time Frame
Day 1-29
Title
Ventilation
Description
Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial
Time Frame
Day 1-29
Title
Hospitalisation - Length
Description
Duration of hospitalisation Length of ICU stay (in days)
Time Frame
Day 1-29
Title
Hospitalisation - Proportion on ICU
Description
Proportion of patients admitted to ICU
Time Frame
Day 1-29
Title
Mortality
Description
15-day, 29-day, 60-day and 90-day all-cause mortality
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Ruiz-Seco, PhD-MD
Organizational Affiliation
Hospital Universitario Infanta Sofía, Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov
City
Kazan
Country
Russian Federation
Facility Name
Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases
City
Kemerovo
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
City
Krasnodar
Country
Russian Federation
Facility Name
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
City
Krasnodar
Country
Russian Federation
Facility Name
State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Ryazan State Medical University n.a. academician I.P. Pavlov
City
Ryazan
Country
Russian Federation
Facility Name
Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"
City
Saint Petersburg
Country
Russian Federation
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
Hospital Universitario Infanta Sofia
City
San Sebastián De Los Reyes
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Asunercept in Patients With Severe COVID-19

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