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

NCT05639192 | Terminated Phase 3 DMC

• 1 other identifier: APG101_CD_018
• Study Type: interventional
• Target: 34
• Locations: 9 countries
• Sites: 39

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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy in reducing progression to more severe disease or death

  Day 1-28

Study Arms (2)

Standard of Care + Asunercept 100 mg

EXPERIMENTAL

Biological: Asunercept

Standard of Care + Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Asunercept BIOLOGICAL

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

Standard of Care + Asunercept 100 mg

Placebo OTHER

Placebo will be administered once per week as an i.v. infusion

Standard of Care + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Apogenix GmbH: lead

Study Sites (39)

Univeritätsklinik für Innere Medizin I

Vienna, Austria

Location

CHU Amiens - Site Sud, Centre de Recherche Clinique

Amiens, France

Location

Dubois Hospital, Service de médecine intensive Réanimation

Brive-la-Gaillarde, France

Location

CHU de Limoges - Hopital Dupuytren

Limoges, France

Location

Georges Pompidou European Hospital

Paris, France

Location

Ltd "Hospital Service"

Kutaisi, Georgia

Location

Ltd "Academician Nikoloz Kipshidze Central University Clinic"

Tbilisi, Georgia

Location

Ltd "Academician Vakhtang Bochorishvili Clinic"

Tbilisi, Georgia

Location

Ltd "TSMU and Ingorokva High Medical Technology University Clinic"

Tbilisi, Georgia

Location

Uniklinik Köln - Klinik I für Innere Medizin

Cologne, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

King George Hospital

Visakhapatnam, Andrha Pradesh, India

Location

Citizen Hospital

Bangalore, Karnataka, India

Location

JSS Hospital

Mysore, Karnataka, India

Location

Spandan Hospital

Pune, Maharashta, India

Location

Govtl. Medical College and Hospital Aurangabad

Aurangabad, Maharashtra, India

Location

PCMC PGI Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, India

Location

Ashirwad Hospital and Research Centre

Ulhasnagar, Maharashtra, India

Location

Atharva Multispecialty Hospital and Research Center

Lucknow, Uttar Pradesh, India

Location

Victoria Hospital, BMCRI Bangalore Medical College & Research Institute

Bangalore, India

Location

KLES Dr. Prabhakar Kore Hospital & Medical Research Center

Nehru Nagar, India

Location

Unity Hospital

Sūrat, India

Location

ASST Santi Paolo e Carlo

Milan, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Italy

Location

Azienda Ospedaliera Universitaria L. Vanvitelli

Napoli, Italy

Location

Azienda Ospedaliere Universitaria Federico I

Napoli, Italy

Location

ZOZ w Boleslawcu

Bolesławiec, Poland

Location

Nicolaus Copernicus Hospital

Koszalin, Poland

Location

Regional Specialist Hospital

Wroclaw, Poland

Location

Global Clinical Trials

Pretoria, Gauteng, South Africa

Location

Lakeview Hospital

Benoni, South Africa

Location

Synapta Clinical Research, 704 Durban Medical Centre

Durban, South Africa

Location

Helen Joseph Hospital

Johannesburg, South Africa

Location

FCRN Clinical Trials Centre

Three Rivers, South Africa

Location

Hospital General Universitario de Alicante Dr. Balmis

Alicante, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro

Vigo, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eike C. Buss, MD

  Apogenix AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 6, 2022
• Study Start: November 3, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: August 29, 2023

Record last verified: 2022-11

Locations

IN (11); IT (4); GE (4); PL (3); DE (2); FR (4); ES (5); ZA (5); AU (1)