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

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

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).

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Asunercept; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eike C. Buss, MD; Phone Number: +49 6221 586080; Email: contact@apogenix.com

Study Locations

• Austria
  • Wien, Austria
    • Univeritätsklinik für Innere Medizin I
• France
  • Amiens, France
    • CHU Amiens - Site Sud, Centre de Recherche Clinique
  • Brive-la-Gaillarde, France
    • Dubois Hospital, Service de médecine intensive Réanimation
  • Limoges, France
    • CHU de Limoges - Hôpital Dupuytren
  • Paris, France
    • Georges Pompidou European Hospital
• Georgia
  • Kutaisi, Georgia
    • Ltd "Hospital Service"
  • Tbilisi, Georgia
    • Ltd "Academician Nikoloz Kipshidze Central University Clinic"
  • Tbilisi, Georgia
    • Ltd "Academician Vakhtang Bochorishvili Clinic"
  • Tbilisi, Georgia
    • Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
• Germany
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Köln, Germany
    • Uniklinik Köln - Klinik I für Innere Medizin
• India
  • Bangalore, India
    • Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
  • Nehru Nagar, India
    • KLES Dr. Prabhakar Kore Hospital & Medical Research Center
  • Sūrat, India
    • Unity Hospital
  • Andrha Pradesh
    • Visakhapatnam, Andrha Pradesh, India
      • King George Hospital
  • Karnataka
    • Bangalore, Karnataka, India
      • Citizen Hospital
    • Mysore, Karnataka, India
      • JSS Hospital
  • Maharashta
    • Pune, Maharashta, India
      • Spandan Hospital
  • Maharashtra
    • Aurangabad, Maharashtra, India
      • Govtl. Medical College and Hospital Aurangabad
    • Pune, Maharashtra, India
      • PCMC PGI Yashwantrao Chavan Memorial Hospital
    • Ulhasnagar, Maharashtra, India
      • Ashirwad Hospital and Research Centre
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India
      • Atharva Multispecialty Hospital and Research Center
• Italy
  • Milan, Italy
    • ASST Santi Paolo e Carlo
  • Milano, Italy
    • ASST Fatebenefratelli Sacco
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria L. Vanvitelli
  • Napoli, Italy
    • Azienda Ospedaliere Universitaria Federico I
• Poland
  • Bolesławiec, Poland
    • ZOZ w Boleslawcu
  • Koszalin, Poland
    • Nicolaus Copernicus Hospital
  • Wrocław, Poland
    • Regional Specialist Hospital
• South Africa
  • Benoni, South Africa
    • Lakeview Hospital
  • Durban, South Africa
    • Synapta Clinical Research, 704 Durban Medical Centre
  • Johannesburg, South Africa
    • Helen Joseph Hospital
  • Three Rivers, South Africa
    • FCRN Clinical Trials Centre
  • Gauteng
    • Pretoria, Gauteng, South Africa
      • Global Clinical Trials
• Spain
  • Alicante, Spain
    • Hospital General Universitario de Alicante Dr. Balmis
  • Barcelona, Spain
    • Hospital del Mar
  • Salamanca, Spain
    • Complejo Asistencial Universitario de Salamanca
  • Valladolid, Spain
    • Hospital Universitario Río Hortega
  • Vigo, Spain
    • Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care + Asunercept 100 mg	Biological: Asunercept; Asunercept (APG101) will be administered once per week as an i.v. infusion
Placebo Comparator: Standard of Care + Placebo	Other: Placebo; Placebo will be administered once per week as an i.v. infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1-56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in reducing progression to more severe disease or death	All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28	Day 1-28

Collaborators and Investigators

• Sponsor: Apogenix GmbH
• Investigators: Study Chair: Eike C. Buss, MD, Apogenix AG

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: APG101_CD_018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No