drugset / Trial / NCT05639192
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asunercept | Protein / enzyme biologic | 100 mg | Intravenous |