Clinical trial NCT05639192: Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Apogenix AG
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Time to sustained recovery
timeFrame: Day 1-56
Secondary outcomes:
measure: Efficacy in reducing progression to more severe disease or death
timeFrame: Day 1-28
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Univeritätsklinik für Innere Medizin I
city: Amiens
country: France
facility: CHU Amiens - Site Sud, Centre de Recherche Clinique
city: Brive-la-Gaillarde
country: France
facility: Dubois Hospital, Service de médecine intensive Réanimation
city: Limoges
country: France
facility: CHU de Limoges - Hopital Dupuytren
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Kutaisi
country: Georgia
facility: Ltd "Hospital Service"
city: Tbilisi
country: Georgia
facility: Ltd "Academician Nikoloz Kipshidze Central University Clinic"
city: Tbilisi
country: Georgia
facility: Ltd "Academician Vakhtang Bochorishvili Clinic"
city: Tbilisi
country: Georgia
facility: Ltd "TSMU and Ingorokva High Medical Technology University Clinic"
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: Uniklinik Köln - Klinik I für Innere Medizin
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andrha Pradesh
city: Bangalore
country: India
facility: Citizen Hospital
state: Karnataka
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Pune
country: India
facility: Spandan Hospital
state: Maharashta
city: Aurangabad
country: India
facility: Govtl. Medical College and Hospital Aurangabad
state: Maharashtra
city: Pune
country: India
facility: PCMC PGI Yashwantrao Chavan Memorial Hospital
state: Maharashtra
city: Ulhasnagar
country: India
facility: Ashirwad Hospital and Research Centre
state: Maharashtra
city: Lucknow
country: India
facility: Atharva Multispecialty Hospital and Research Center
state: Uttar Pradesh
city: Bangalore
country: India
facility: Victoria Hospital, BMCRI Bangalore Medical College & Research Institute
city: Nehru Nagar
country: India
facility: KLES Dr. Prabhakar Kore Hospital & Medical Research Center
city: Sūrat
country: India
facility: Unity Hospital
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milan
country: Italy
facility: ASST Santi Paolo e Carlo
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria L. Vanvitelli
city: Napoli
country: Italy
facility: Azienda Ospedaliere Universitaria Federico I
city: Bolesławiec
country: Poland
facility: ZOZ w Boleslawcu
city: Koszalin
country: Poland
facility: Nicolaus Copernicus Hospital
city: Wrocław
country: Poland
facility: Regional Specialist Hospital
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Benoni
country: South Africa
facility: Lakeview Hospital
city: Durban
country: South Africa
facility: Synapta Clinical Research, 704 Durban Medical Centre
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital
city: Three Rivers
country: South Africa
facility: FCRN Clinical Trials Centre
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro
Study officials:
affiliation: Apogenix AG
name: Eike C. Buss, MD
role: STUDY_CHAIR
References: