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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001887-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | ||
| Standard of Care + Asunercept 25 mg | Experimental |
| |
| Standard of Care + Asunercept 100 mg | Experimental |
| |
| Standard of Care + Asunercept 400 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asunercept | Biological | Asunercept (APG101) will be administered once per week as an i.v. infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1-29 |
| Oxygenation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Ruiz-Seco, PhD-MD | Hospital Universitario Infanta Sofía, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov | Kazan' | Russia | ||||
| Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39513186 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
| Day 1-29 |
| Ventilation | Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial | Day 1-29 |
| Hospitalisation - Length | Duration of hospitalisation Length of ICU stay (in days) | Day 1-29 |
| Hospitalisation - Proportion on ICU | Proportion of patients admitted to ICU | Day 1-29 |
| Mortality | 15-day, 29-day, 60-day and 90-day all-cause mortality | Up to 90 days |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |