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

NCT ID: NCT05639192

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2023-08-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard of Care + Asunercept 100 mg

Group Type: EXPERIMENTAL

Asunercept

Intervention Type: BIOLOGICAL

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

Standard of Care + Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Asunercept

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apogenix GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eike C. Buss, MD

Role: STUDY_CHAIR

Apogenix AG

Locations

Univeritätsklinik für Innere Medizin I

Vienna, , Austria

CHU Amiens - Site Sud, Centre de Recherche Clinique

Amiens, , France

Dubois Hospital, Service de médecine intensive Réanimation

Brive-la-Gaillarde, , France

CHU de Limoges - Hopital Dupuytren

Limoges, , France

Georges Pompidou European Hospital

Paris, , France

Ltd "Hospital Service"

Kutaisi, , 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"

Tbilisi, , Georgia

Uniklinik Köln - Klinik I für Innere Medizin

Cologne, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

King George Hospital

Visakhapatnam, Andrha Pradesh, India

Citizen Hospital

Bangalore, Karnataka, India

JSS Hospital

Mysore, Karnataka, India

Spandan Hospital

Pune, Maharashta, India

Govtl. Medical College and Hospital Aurangabad

Aurangabad, Maharashtra, India

PCMC PGI Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, India

Ashirwad Hospital and Research Centre

Ulhasnagar, Maharashtra, India

Atharva Multispecialty Hospital and Research Center

Lucknow, Uttar Pradesh, India

Victoria Hospital, BMCRI Bangalore Medical College & Research Institute

Bangalore, , India

KLES Dr. Prabhakar Kore Hospital & Medical Research Center

Nehru Nagar, , India

Unity Hospital

Sūrat, , India

ASST Santi Paolo e Carlo

Milan, , Italy

ASST Fatebenefratelli Sacco

Milan, , Italy

Azienda Ospedaliera Universitaria L. Vanvitelli

Napoli, , Italy

Azienda Ospedaliere Universitaria Federico I

Napoli, , Italy

ZOZ w Boleslawcu

Bolesławiec, , Poland

Nicolaus Copernicus Hospital

Koszalin, , Poland

Regional Specialist Hospital

Wroclaw, , Poland

Global Clinical Trials

Pretoria, Gauteng, South Africa

Lakeview Hospital

Benoni, , South Africa

Synapta Clinical Research, 704 Durban Medical Centre

Durban, , South Africa

Helen Joseph Hospital

Johannesburg, , South Africa

FCRN Clinical Trials Centre

Three Rivers, , South Africa

Hospital General Universitario de Alicante Dr. Balmis

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Río Hortega

Valladolid, , Spain

Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro

Vigo, , Spain

Countries

Austria; France; Georgia; Germany; India; Italy; Poland; South Africa; Spain

Other Identifiers

APG101_CD_018

Identifier Type: -

Identifier Source: org_study_id