drugset / Trial / NCT05639192

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

NCT05639192

Phase 3 Terminated 34 enrolled Apogenix GmbH
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2022-11-03
Primary completion
2023-08-18
Completion
2023-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunercept Protein / enzyme biologic 100 mg Intravenous

Indications