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

Phase 3

Terminated

• Conditions: COVID-19
• Interventions: Other: Placebo; Biological: Asunercept

• Registration Number: NCT05639192
• Lead Sponsor: Apogenix GmbH

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-03
• Study First Submitted: 2022-12-03
• Study First Submitted QC: 2022-12-03
• Study First Posted: 2022-12-06
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + Placebo	Placebo	-
Standard of Care + Asunercept 100 mg	Asunercept	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (39)

Hospital del Mar; 🇪🇸 Barcelona, Spain

CHU de Limoges - Hopital Dupuytren; 🇫🇷 Limoges, France

Georges Pompidou European Hospital; 🇫🇷 Paris, France

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Uniklinik Köln - Klinik I für Innere Medizin; 🇩🇪 Köln, Germany

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

CHU Amiens - Site Sud, Centre de Recherche Clinique; 🇫🇷 Amiens, France

Dubois Hospital, Service de médecine intensive Réanimation; 🇫🇷 Brive-la-Gaillarde, France

Global Clinical Trials; 🇿🇦 Pretoria, Gauteng, South Africa

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

Hospital General Universitario de Alicante Dr. Balmis; 🇪🇸 Alicante, Spain

JSS Hospital; 🇮🇳 Mysore, Karnataka, India

Govtl. Medical College and Hospital Aurangabad; 🇮🇳 Aurangabad, Maharashtra, India

PCMC PGI Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, Maharashtra, India

Victoria Hospital, BMCRI Bangalore Medical College & Research Institute; 🇮🇳 Bangalore, India

KLES Dr. Prabhakar Kore Hospital & Medical Research Center; 🇮🇳 Nehru Nagar, India

Nicolaus Copernicus Hospital; 🇵🇱 Koszalin, Poland

Regional Specialist Hospital; 🇵🇱 Wrocław, Poland

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

ASST Fatebenefratelli Sacco; 🇮🇹 Milano, Italy

ASST Santi Paolo e Carlo; 🇮🇹 Milan, Italy

Azienda Ospedaliera Universitaria L. Vanvitelli; 🇮🇹 Napoli, Italy

Azienda Ospedaliere Universitaria Federico I; 🇮🇹 Napoli, Italy

Ltd "Academician Nikoloz Kipshidze Central University Clinic"; 🇬🇪 Tbilisi, Georgia

Univeritätsklinik für Innere Medizin I; 🇦🇹 Wien, Austria

King George Hospital; 🇮🇳 Visakhapatnam, Andrha Pradesh, India

Spandan Hospital; 🇮🇳 Pune, Maharashta, India

Ltd "Hospital Service"; 🇬🇪 Kutaisi, Georgia

Ltd "Academician Vakhtang Bochorishvili Clinic"; 🇬🇪 Tbilisi, Georgia

Citizen Hospital; 🇮🇳 Bangalore, Karnataka, India

Ltd "TSMU and Ingorokva High Medical Technology University Clinic"; 🇬🇪 Tbilisi, Georgia

Ashirwad Hospital and Research Centre; 🇮🇳 Ulhasnagar, Maharashtra, India

Atharva Multispecialty Hospital and Research Center; 🇮🇳 Lucknow, Uttar Pradesh, India

ZOZ w Boleslawcu; 🇵🇱 Bolesławiec, Poland

Unity Hospital; 🇮🇳 Sūrat, India