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Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease (ASUCOV)

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Asunercept
Placebo
Sponsored by
Apogenix GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria: Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol ≥18 years of age Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment Patient agrees to not participate in another clinical trial from screening until day 56 Exclusion Criteria: Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.) Patient is anticipated to be discharged from hospital within 48 hours Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) Patient requires invasive mechanical ventilation Patient is known to have active tuberculosis Patient is known to have hereditary fructose intolerance. Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).

Sites / Locations

  • Univeritätsklinik für Innere Medizin I
  • CHU Amiens - Site Sud, Centre de Recherche Clinique
  • Dubois Hospital, Service de médecine intensive Réanimation
  • CHU de Limoges - Hopital Dupuytren
  • Georges Pompidou European Hospital
  • Ltd "Hospital Service"
  • Ltd "Academician Nikoloz Kipshidze Central University Clinic"
  • Ltd "Academician Vakhtang Bochorishvili Clinic"
  • Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
  • Universitätsklinikum Heidelberg
  • Uniklinik Köln - Klinik I für Innere Medizin
  • King George Hospital
  • Citizen Hospital
  • JSS Hospital
  • Spandan Hospital
  • Govtl. Medical College and Hospital Aurangabad
  • PCMC PGI Yashwantrao Chavan Memorial Hospital
  • Ashirwad Hospital and Research Centre
  • Atharva Multispecialty Hospital and Research Center
  • Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
  • KLES Dr. Prabhakar Kore Hospital & Medical Research Center
  • Unity Hospital
  • ASST Fatebenefratelli Sacco
  • ASST Santi Paolo e Carlo
  • Azienda Ospedaliera Universitaria L. Vanvitelli
  • Azienda Ospedaliere Universitaria Federico I
  • ZOZ w Boleslawcu
  • Nicolaus Copernicus Hospital
  • Regional Specialist Hospital
  • Global Clinical Trials
  • Lakeview Hospital
  • Synapta Clinical Research, 704 Durban Medical Centre
  • Helen Joseph Hospital
  • FCRN Clinical Trials Centre
  • Hospital General Universitario de Alicante Dr. Balmis
  • Hospital del Mar
  • Complejo Asistencial Universitario de Salamanca
  • Hospital Universitario Río Hortega
  • Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Standard of Care + Asunercept 100 mg

Standard of Care + Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to sustained recovery
Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.

Secondary Outcome Measures

Efficacy in reducing progression to more severe disease or death
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28

Full Information

First Posted
December 3, 2022
Last Updated
August 28, 2023
Sponsor
Apogenix GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05639192
Brief Title
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
Acronym
ASUCOV
Official Title
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
August 18, 2023 (Actual)
Study Completion Date
August 18, 2023 (Actual)

3. Sponsor/Collaborators

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

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 clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10). The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care + Asunercept 100 mg
Arm Type
Experimental
Arm Title
Standard of Care + Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Asunercept
Intervention Description
Asunercept (APG101) will be administered once per week as an i.v. infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered once per week as an i.v. infusion
Primary Outcome Measure Information:
Title
Time to sustained recovery
Description
Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.
Time Frame
Day 1-56
Secondary Outcome Measure Information:
Title
Efficacy in reducing progression to more severe disease or death
Description
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28
Time Frame
Day 1-28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol ≥18 years of age Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment Patient agrees to not participate in another clinical trial from screening until day 56 Exclusion Criteria: Patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.) Patient is anticipated to be discharged from hospital within 48 hours Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) Patient requires invasive mechanical ventilation Patient is known to have active tuberculosis Patient is known to have hereditary fructose intolerance. Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eike C. Buss, MD
Organizational Affiliation
Apogenix AG
Official's Role
Study Chair
Facility Information:
Facility Name
Univeritätsklinik für Innere Medizin I
City
Wien
Country
Austria
Facility Name
CHU Amiens - Site Sud, Centre de Recherche Clinique
City
Amiens
Country
France
Facility Name
Dubois Hospital, Service de médecine intensive Réanimation
City
Brive-la-Gaillarde
Country
France
Facility Name
CHU de Limoges - Hopital Dupuytren
City
Limoges
Country
France
Facility Name
Georges Pompidou European Hospital
City
Paris
Country
France
Facility Name
Ltd "Hospital Service"
City
Kutaisi
Country
Georgia
Facility Name
Ltd "Academician Nikoloz Kipshidze Central University Clinic"
City
Tbilisi
Country
Georgia
Facility Name
Ltd "Academician Vakhtang Bochorishvili Clinic"
City
Tbilisi
Country
Georgia
Facility Name
Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
City
Tbilisi
Country
Georgia
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Uniklinik Köln - Klinik I für Innere Medizin
City
Köln
Country
Germany
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andrha Pradesh
Country
India
Facility Name
Citizen Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
JSS Hospital
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Spandan Hospital
City
Pune
State/Province
Maharashta
Country
India
Facility Name
Govtl. Medical College and Hospital Aurangabad
City
Aurangabad
State/Province
Maharashtra
Country
India
Facility Name
PCMC PGI Yashwantrao Chavan Memorial Hospital
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Ashirwad Hospital and Research Centre
City
Ulhasnagar
State/Province
Maharashtra
Country
India
Facility Name
Atharva Multispecialty Hospital and Research Center
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
City
Bangalore
Country
India
Facility Name
KLES Dr. Prabhakar Kore Hospital & Medical Research Center
City
Nehru Nagar
Country
India
Facility Name
Unity Hospital
City
Sūrat
Country
India
Facility Name
ASST Fatebenefratelli Sacco
City
Milano
Country
Italy
Facility Name
ASST Santi Paolo e Carlo
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria L. Vanvitelli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliere Universitaria Federico I
City
Napoli
Country
Italy
Facility Name
ZOZ w Boleslawcu
City
Bolesławiec
Country
Poland
Facility Name
Nicolaus Copernicus Hospital
City
Koszalin
Country
Poland
Facility Name
Regional Specialist Hospital
City
Wrocław
Country
Poland
Facility Name
Global Clinical Trials
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Lakeview Hospital
City
Benoni
Country
South Africa
Facility Name
Synapta Clinical Research, 704 Durban Medical Centre
City
Durban
Country
South Africa
Facility Name
Helen Joseph Hospital
City
Johannesburg
Country
South Africa
Facility Name
FCRN Clinical Trials Centre
City
Three Rivers
Country
South Africa
Facility Name
Hospital General Universitario de Alicante Dr. Balmis
City
Alicante
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Río Hortega
City
Valladolid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro
City
Vigo
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease

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