Asunercept in Patients With Severe COVID-19

NCT04535674 | Completed Phase 2 DMC

• 2 other identifiers: APG101_CD_0172020-001887-27
• Study Type: interventional
• Target: 438
• Locations: 2 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Time to sustained improvement of one category (i.e. two consecutive days) from randomisation

  The primary endpoint is time to clinical improvement which is defined as time from randomisation to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomisation measured on a nine-category ordinal scale (proposed by WHO).

  Day 1-29

Secondary Outcomes (6)

• Efficacy according to the National Early Warning Score (NEWS)

  Day 1-29

• Oxygenation

  Day 1-29

• Ventilation

  Day 1-29

• Hospitalisation - Length

  Day 1-29

• Hospitalisation - Proportion on ICU

  Day 1-29

Study Arms (4)

Standard of Care

NO INTERVENTION

Standard of Care + Asunercept 25 mg

EXPERIMENTAL

Biological: Asunercept

Standard of Care + Asunercept 100 mg

EXPERIMENTAL

Biological: Asunercept

Standard of Care + Asunercept 400 mg

EXPERIMENTAL

Biological: Asunercept

Interventions

Asunercept BIOLOGICAL

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

Standard of Care + Asunercept 100 mg; Standard of Care + Asunercept 25 mg; Standard of Care + Asunercept 400 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Apogenix AG: lead

Study Sites (13)

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

Kazan', Russia

Location

Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases

Kemerovo, Russia

Location

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

Krasnodar, Russia

Location

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

Location

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

Nizhny Novgorod, Russia

Location

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

Ryazan, Russia

Location

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

Saint Petersburg, Russia

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (1)

• 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.

  PMID: 39513186 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pilar Ruiz-Seco, PhD-MD

  Hospital Universitario Infanta Sofía, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Asunercept/APG101 will be tested in three parallel intervention arms and compared with Standard of Care (SoC). The study will compare treatment efficacy of SoC to that of weekly intravenous infusions of Asunercept at three different doses. Patients will be randomised into four groups.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 2, 2020
• Study Start: October 9, 2020
• Primary Completion: October 29, 2021
• Study Completion: December 21, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); RU (7)