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

Phase 3

Terminated

• Conditions: COVID-19

• 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

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Univeritätsklinik für Innere Medizin I; 🇦🇹 Wien, 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

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

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