Asunercept in Patients With Severe COVID-19 (ASUNCTIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04535674 |
Recruitment Status :
Completed
First Posted : September 2, 2020
Last Update Posted : January 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 Induced Pneumonia Covid19 | Biological: Asunercept | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 438 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease |
Actual Study Start Date : | October 9, 2020 |
Actual Primary Completion Date : | October 29, 2021 |
Actual Study Completion Date : | December 21, 2021 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard of Care | |
Experimental: Standard of Care + Asunercept 25 mg |
Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion |
Experimental: Standard of Care + Asunercept 100 mg |
Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion |
Experimental: Standard of Care + Asunercept 400 mg |
Biological: Asunercept
Asunercept (APG101) will be administered once per week as an i.v. infusion |
- Time to sustained improvement of one category (i.e. two consecutive days) from randomisation [ Time Frame: Day 1-29 ]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).
- Efficacy according to the National Early Warning Score (NEWS) [ Time Frame: Day 1-29 ]Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first Change from baseline
- Oxygenation [ Time Frame: Day 1-29 ]Oxygenation free days until day 29 Incidence and duration of new oxygen use during the trial
- Ventilation [ Time Frame: Day 1-29 ]Ventilator free days until day 29 Incidence and duration fo new mechanical ventilation use during the trial
- Hospitalisation - Length [ Time Frame: Day 1-29 ]Duration of hospitalisation Length of ICU stay (in days)
- Hospitalisation - Proportion on ICU [ Time Frame: Day 1-29 ]Proportion of patients admitted to ICU
- Mortality [ Time Frame: Up to 90 days ]15-day, 29-day, 60-day and 90-day all-cause mortality

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535674
Russian Federation | |
Republican Clinical Infectious Hospital n.a. professor A.F. Agafonov | |
Kazan, Russian Federation | |
Scientific Research lnstitute fоr Соmрlех lssues of Cardiovascular Diseases | |
Kemerovo, Russian Federation | |
Federal State Budgetary Educational Institution of Higher Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation | |
Krasnodar, Russian Federation | |
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, Russian Federation | |
State Budgetary Institution of Health of the Nizhny Novgorod Region "Infectious Clinical Hospital No. 2 of Nizhny Novgorod" | |
Nizhny Novgorod, Russian Federation | |
Ryazan State Medical University n.a. academician I.P. Pavlov | |
Ryazan, Russian Federation | |
Saint Petersburg state budgetary healthcare institution "City hospital of Saint George the great Martyr" | |
Saint Petersburg, Russian Federation | |
Spain | |
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 |
Principal Investigator: | Pilar Ruiz-Seco, PhD-MD | Hospital Universitario Infanta Sofía, Madrid |
Responsible Party: | Apogenix AG |
ClinicalTrials.gov Identifier: | NCT04535674 |
Other Study ID Numbers: |
APG101_CD_017 2020-001887-27 ( EudraCT Number ) |
First Posted: | September 2, 2020 Key Record Dates |
Last Update Posted: | January 14, 2022 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |