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COVID-19 Induced PneumoniaPhase 2ASUNCTISNCT04535674

Asunercept in Patients With Severe COVID-19

A Phase 2 study testing Asunercept in people with COVID-19 Induced Pneumonia and Covid19, run by Apogenix AG at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Induced Pneumonia, Covid19
What is being tested?
Asunercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
13 sitesin 2 countries
Study dates
9 Oct 2020to 21 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • Mechanical ventilation for >48 hours
  • Known active HIV or viral hepatitis infection
  • Known active tuberculosis
  • Known hereditary fructose intolerance

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Russia7 sites

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

    Kazan'

  • Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases

    Kemerovo

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

    Krasnodar

  • 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

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

    Nizhny Novgorod

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

    Ryazan

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

    Saint Petersburg

Other trials in Russia

Spain6 sites

  • Hospital Universitario Infanta Leonor

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

Official title: A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease

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.

Being tested
Asunercept
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsunerceptBiological

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

Study groups in NCT04535674
Study groupRoleWhat they receive
Standard of CareNo interventionNot described
Standard of Care + Asunercept 25 mgExperimentalNot described
Receives: Biological: Asunercept
Standard of Care + Asunercept 100 mgExperimentalNot described
Receives: Biological: Asunercept
Standard of Care + Asunercept 400 mgExperimentalNot described
Receives: Biological: Asunercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 1-29

Secondary outcomes (6)

  1. Efficacy according to the National Early Warning Score (NEWS)

    Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline

    Measured: Day 1-29

  2. Oxygenation

    Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial

    Measured: Day 1-29

  3. Ventilation

    Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial

    Measured: Day 1-29

  4. Hospitalisation - Length

    Duration of hospitalisation Length of ICU stay (in days)

    Measured: Day 1-29

  5. Hospitalisation - Proportion on ICU

    Proportion of patients admitted to ICU

    Measured: Day 1-29

  6. Mortality

    15-day, 29-day, 60-day and 90-day all-cause mortality

    Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start9 Oct 2020
  3. Primary completion29 Oct 2021
  4. Study completion21 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04535674
Sponsor's protocol ID
APG101_CD_017
Other IDs
2020-001887-27
Acronym
ASUNCTIS
Status last verified
Jul 2021
First submitted
31 Aug 2020
Last updated
14 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39513186

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Asunercept in people with COVID-19 Induced Pneumonia and Covid19, run by Apogenix AG at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Russia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to sustained improvement of one category (i.e. two consecutive days) from randomisation (time frame: Day 1-29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.

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