NCT05639192

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Apogenix GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-03
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2022-12-06
• Last updated: 2023-08-29

Locations

39 sites across 9 countries: Austria, France, Georgia, Germany, India, Italy, Poland, South Africa, Spain