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Asunercept in Patients With Severe COVID-19

NCT04535674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2022-01-14

No results posted yet for this study

Summary

This is an open-label, randomized, phase II study with the main objective to investigate the effectiveness and safety of an investigational drug (APG101; International Nonproprietary Name: asunercept) in patients with severe COVID-19 disease. The study aims to decrease overall and SARS-CoV-2 associated pneumonia mortality in patients with COVID-19 as well as to decrease the percentage of patients admitted to Intensive Care Unit (ICU), decrease the need to supply oxygen to patients, reduce the number of days patients are hospitalized in ICU and/or on the ward, decrease the number of days required to obtain a negative result in the PCR (Polymerase Chain Reaction, a laboratory technique that allows the amplification of small fragments of DNA to detect the presence of the virus) test for COVID-19 and decrease the levels of markers that indicate pneumonia.

Conditions

  • COVID-19 Induced Pneumonia
  • Covid19

Interventions

BIOLOGICAL

Asunercept

Asunercept (APG101) will be administered once per week as an i.v. infusion

Sponsors & Collaborators

  • Apogenix AG

    lead INDUSTRY

Principal Investigators

  • Pilar Ruiz-Seco, PhD-MD · Hospital Universitario Infanta Sofía, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2021-10-29
Completion
2021-12-21

Countries

  • Russia
  • Spain

Study Locations

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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 NCT04535674 on ClinicalTrials.gov