ASUNCTIS: Asunercept in Patients With Severe COVID-19

Sponsor
Apogenix AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04535674
Collaborator
(none)
400
Enrollment
14
Locations
4
Arms
13.7
Anticipated Duration (Months)
28.6
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Asunercept
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Oct 9, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
No Intervention: Standard of Care

Experimental: Standard of Care + Asunercept 25 mg

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

Experimental: Standard of Care + Asunercept 100 mg

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

Experimental: Standard of Care + Asunercept 400 mg

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

Outcome Measures

Primary Outcome Measures

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

    Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial

  3. Ventilation [Day 1-29]

    Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial

  4. Hospitalisation - Length [Day 1-29]

    Duration of hospitalisation Length of ICU stay (in days)

  5. Hospitalisation - Proportion on ICU [Day 1-29]

    Proportion of patients admitted to ICU

  6. Mortality [Up to 90 days]

    15-day, 29-day, 60-day and 90-day all-cause mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Republican Clinical Infectious Hospital n.a. professor A.F. AgafonovKazanRussian Federation
2Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular DiseasesKemerovoRussian Federation
3Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian FederationKrasnodarRussian Federation
4State Budgetary Healthcare Institution "Scientific Research Institute - Regional clinical hospital No. 1 n.a. professor S.V. Ochapovsky" of the Ministry of Healthcare of Krasnodar KraiKrasnodarRussian Federation
5Kursk Regional Clinical HospitalKurskRussian Federation
6State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"Nizhny NovgorodRussian Federation
7Ryazan State Medical University n.a. academician I.P. PavlovRyazanRussian Federation
8Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"Saint PetersburgRussian Federation
9Hospital Universitario Infanta LeonorMadridSpain
10Hospital Universitario La PazMadridSpain
11Hospital Universitario Ramón y CajalMadridSpain
12Hospital Universitario Puerta de Hierro MajadahondaMajadahondaSpain
13Hospital Universitario Infanta SofiaSan Sebastián De Los ReyesSpain
14Hospital Clínico Universitario Lozano BlesaZaragozaSpain

Sponsors and Collaborators

  • Apogenix AG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Apogenix AG
ClinicalTrials.gov Identifier:
NCT04535674
Other Study ID Numbers:
  • APG101_CD_017
  • 2020-001887-27
First Posted:
Sep 2, 2020
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2021