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

Sponsor

Apogenix AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05639192

Collaborator

(none)

636

Enrollment

Locations

Arms

12.9

Anticipated Duration (Months)

17.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: Asunercept Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

636 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 3, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to sustained recovery [Day 1-56]
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.

Secondary Outcome Measures

Efficacy in reducing progression to more severe disease or death [Day 1-28]
All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country
1	Univeritätsklinik für Innere Medizin I	Wien		Austria
2	CHU Amiens - Site Sud, Centre de Recherche Clinique	Amiens		France
3	CHU de Limoges - Hopital Dupuytren	Limoges		France
4	Georges Pompidou European Hospital	Paris		France
5	Ltd "Hospital Service"	Kutaisi		Georgia
6	LEPL "The first University Clinic of TSMU"	Tbilisi		Georgia
7	Ltd "Academician Nikoloz Kipshidze Central University Clinic"	Tbilisi		Georgia
8	Ltd "Academician Vakhtang Bochorishvili Clinic"	Tbilisi		Georgia
9	Ltd "TSMU and Ingorokva High Medical Technology University Clinic"	Tbilisi		Georgia
10	Universitätsklinikum Heidelberg	Heidelberg		Germany
11	Uniklinik Köln - Klinik I für Innere Medizin	Köln		Germany
12	King George Hospital	Visakhapatnam	Andrha Pradesh	India
13	Citizen Hospital	Bangalore	Karnataka	India
14	JSS Hospital	Mysore	Karnataka	India
15	Spandan Hospital	Pune	Maharashta	India
16	Govtl. Medical College and Hospital Aurangabad	Aurangabad	Maharashtra	India
17	PCMC PGI Yashwantrao Chavan Memorial Hospital	Pune	Maharashtra	India
18	Atharva Multispecialty Hospital and Research Center	Lucknow	Uttar Pradesh	India
19	Victoria Hospital, BMCRI Bangalore Medical College & Research Institute	Bangalore		India
20	KLES Dr. Prabhakar Kore Hospital & Medical Research Center	Nehru Nagar		India
21	Unity Hospital	Sūrat		India
22	ASST Fatebenefratelli Sacco	Milano		Italy
23	ASST Santi Paolo e Carlo	Milan		Italy
24	Azienda Ospedaliera Universitaria L. Vanvitelli	Napoli		Italy
25	Azienda Ospedaliere Universitaria Federico I	Napoli		Italy
26	ZOZ w Boleslawcu	Bolesławiec		Poland
27	Nicolaus Copernicus Hospital	Koszalin		Poland
28	Regional Specialist Hospital	Wrocław		Poland
29	Lakeview Hospital	Benoni		South Africa
30	Helen Joseph Hospital	Johannesburg		South Africa
31	FCRN Clinical Trials Centre	Three Rivers		South Africa
32	Hospital General Universitario de Alicante Dr. Balmis	Alicante		Spain
33	Hospital del Mar	Barcelona		Spain
34	Complejo Asistencial Universitario de Salamanca	Salamanca		Spain
35	Hospital Universitario Río Hortega	Valladolid		Spain
36	Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro	Vigo		Spain

Sponsors and Collaborators

Apogenix AG

Investigators

Study Chair: Eike C. Buss, MD, Apogenix AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Apogenix AG

ClinicalTrials.gov Identifier:

NCT05639192

Other Study ID Numbers:

APG101_CD_018

First Posted:

Dec 6, 2022

Last Update Posted:

Dec 8, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 8, 2022