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

NCT05639192 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-08-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Apogenix GmbH

    lead INDUSTRY

Principal Investigators

  • Eike C. Buss, MD · Apogenix AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Austria
  • France
  • Georgia
  • Germany
  • India
  • Italy
  • Poland
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639192 on ClinicalTrials.gov