Asunercept in Patients With Severe COVID-19

NCT ID: NCT04535674

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2021-12-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard of Care + Asunercept 25 mg

Group Type: EXPERIMENTAL

Asunercept

Intervention Type: BIOLOGICAL

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

Standard of Care + Asunercept 100 mg

Group Type: EXPERIMENTAL

Asunercept

Intervention Type: BIOLOGICAL

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

Standard of Care + Asunercept 400 mg

Group Type: EXPERIMENTAL

Asunercept

Intervention Type: BIOLOGICAL

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

Interventions

Asunercept

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of SARS-CoV-2 infection
• Hospitalisation due to COVID-19
• Informed Consent obtained, the patient understands and agrees to comply with the planned study procedures. If a potential patient is unconscious, the Patient Information Sheet with the Informed Consent Form can be signed by the legal representative, if he/she accompanies the patient. It can be signed by a Concilium consisting of doctors (2), investigator and an independent witness in case the legal representative is not available.
• ≥18 years of age
• Willingness to perform effective measures of contraception during the study.
• Signs of respiratory deterioration such as oxygen saturation ≤94% when breathing ambient air or >3% drop in oxygen saturation in case of chronic obstructive lung disease OR need for oxygen supplementation to achieve satisfactory blood oxygen saturation (sPO2>90% at room air) as well as the need for non-invasive ventilation, high-flow oxygen devices or mechanical ventilation or radiological or clinical signs of pneumonia.

Exclusion Criteria

• Moribund, or estimated life expectancy <1 month (e.g., terminal cancer, etc.)
• Patient does not qualify for intensive care, based on local triage criteria
• Pregnancy or breast feeding
• Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)
• Anticipated discharge from hospital within 48 hours
• Other potent anti-inflammatory treatment, e.g. TNF- blocking therapies
• Mechanical ventilation for >48 hours
• Known active HIV or viral hepatitis infection
• Known active tuberculosis
• Known hereditary fructose intolerance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apogenix AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pilar Ruiz-Seco, PhD-MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Infanta Sofía, Madrid

Locations

Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov

Kazan', , Russia

Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases

Kemerovo, , Russia

Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation

Krasnodar, , Russia

State Budgetary Healthcare Institution "Scientific Research Institute - Regional clinical hospital No. 1 n.a. professor S.V. Ochapovsky" of the Ministry of Healthcare of Krasnodar Krai

Krasnodar, , Russia

State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod"

Nizhny Novgorod, , Russia

Ryazan State Medical University n.a. academician I.P. Pavlov

Ryazan, , Russia

Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr"

Saint Petersburg, , Russia

Hospital Universitario Infanta Leonor

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Countries

Russia; Spain

References

Ruiz Seco MP, Pano Pardo JR, Schoergenhofer C, Dings C, Lehr T, Herth F, Krendyukov A, Straub C, Kappler M, Jilma B, Fricke H, Pardo J, de Miguel D, Thiemann M, Bergmann M, Walczak H, Hoeger T. Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial. EClinicalMedicine. 2024 Oct 24;77:102879. doi: 10.1016/j.eclinm.2024.102879. eCollection 2024 Nov.

Reference Type: DERIVED

PMID: 39513186 (View on PubMed)

Other Identifiers

2020-001887-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APG101_CD_017

Identifier Type: -

Identifier Source: org_study_id