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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05639192
• Other study ID #: APG101_CD_018
• Status: Terminated
• Phase: Phase 3
• Start date: November 3, 2022
• Est. completion date: August 18, 2023

Study information

• Verified date: November 2022
• Source: Apogenix AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

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

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

Locations

Country	Name	City	State
Austria	Univeritätsklinik für Innere Medizin I	Wien
France	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
Georgia	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
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Uniklinik Köln - Klinik I für Innere Medizin	Köln
India	Govtl. Medical College and Hospital Aurangabad	Aurangabad	Maharashtra
India	Citizen Hospital	Bangalore	Karnataka
India	Victoria Hospital, BMCRI Bangalore Medical College & Research Institute	Bangalore
India	Atharva Multispecialty Hospital and Research Center	Lucknow	Uttar Pradesh
India	JSS Hospital	Mysore	Karnataka
India	KLES Dr. Prabhakar Kore Hospital & Medical Research Center	Nehru Nagar
India	PCMC PGI Yashwantrao Chavan Memorial Hospital	Pune	Maharashtra
India	Spandan Hospital	Pune	Maharashta
India	Unity Hospital	Surat
India	Ashirwad Hospital and Research Centre	Ulhasnagar	Maharashtra
India	King George Hospital	Visakhapatnam	Andrha Pradesh
Italy	ASST Santi Paolo e Carlo	Milan
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	Azienda Ospedaliera Universitaria L. Vanvitelli	Napoli
Italy	Azienda Ospedaliere Universitaria Federico I	Napoli
Poland	ZOZ w Boleslawcu	Boleslawiec
Poland	Nicolaus Copernicus Hospital	Koszalin
Poland	Regional Specialist Hospital	Wroclaw
South Africa	Lakeview Hospital	Benoni
South Africa	Synapta Clinical Research, 704 Durban Medical Centre	Durban
South Africa	Helen Joseph Hospital	Johannesburg
South Africa	Global Clinical Trials	Pretoria	Gauteng
South Africa	FCRN Clinical Trials Centre	Three Rivers
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Apogenix GmbH

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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