Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 5:49 AM
Study NCT ID:
NCT05639192
Status:
TERMINATED
Last Update Posted:
2023-08-29
First Post:
2022-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Lack of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2022-12-03', 'studyFirstSubmitQcDate': '2022-12-03', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to sustained recovery', 'timeFrame': 'Day 1-56', 'description': 'Sustained improvement (i.e., without decrease) of ≥2 points on the WHO 10 point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Efficacy in reducing progression to more severe disease or death', 'timeFrame': 'Day 1-28', 'description': 'All-cause mortality or progression to invasive mechanical ventilation (IMV) by d28'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10).\n\nThe investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol\n* ≥18 years of age\n* Patient is admitted to a hospital (max. 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test\n* Clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the WHO 10-point clinical progression scale) with COVID 19 prior to trial treatment\n* Patient agrees to not participate in another clinical trial from screening until day 56\n\nExclusion Criteria:\n\n* Patient is moribund or has an estimated life expectancy \\<1 month (e.g., terminal cancer, etc.)\n* Patient is anticipated to be discharged from hospital within 48 hours\n* Patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)\n* Patient requires invasive mechanical ventilation\n* Patient is known to have active tuberculosis\n* Patient is known to have hereditary fructose intolerance.\n* Patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus \\[RSV\\], parainfluenza viruses, respiratory adenoviruses).'}, 'identificationModule': {'nctId': 'NCT05639192', 'acronym': 'ASUCOV', 'briefTitle': 'Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apogenix AG'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease', 'orgStudyIdInfo': {'id': 'APG101_CD_018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard of Care + Asunercept 100 mg', 'interventionNames': ['Biological: Asunercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care + Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Asunercept', 'type': 'BIOLOGICAL', 'description': 'Asunercept (APG101) will be administered once per week as an i.v. infusion', 'armGroupLabels': ['Standard of Care + Asunercept 100 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be administered once per week as an i.v. infusion', 'armGroupLabels': ['Standard of Care + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Univeritätsklinik für Innere Medizin I', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens - Site Sud, Centre de Recherche Clinique', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Dubois Hospital, Service de médecine intensive Réanimation', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges - Hopital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Paris', 'country': 'France', 'facility': 'Georges Pompidou European Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Kutaisi', 'country': 'Georgia', 'facility': 'Ltd "Hospital Service"', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ltd "Academician Nikoloz Kipshidze Central University Clinic"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ltd "Academician Vakhtang Bochorishvili Clinic"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ltd "TSMU and Ingorokva High Medical Technology University Clinic"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Köln - Klinik I für Innere Medizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Visakhapatnam', 'state': 'Andrha Pradesh', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Citizen Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'JSS Hospital', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'city': 'Pune', 'state': 'Maharashta', 'country': 'India', 'facility': 'Spandan Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Aurangabad', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Govtl. Medical College and Hospital Aurangabad', 'geoPoint': {'lat': 19.87757, 'lon': 75.34226}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'PCMC PGI Yashwantrao Chavan Memorial Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Ulhasnagar', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Ashirwad Hospital and Research Centre', 'geoPoint': {'lat': 19.21667, 'lon': 73.15}}, {'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Atharva Multispecialty Hospital and Research Center', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Victoria Hospital, BMCRI Bangalore Medical College & Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Nehru Nagar', 'country': 'India', 'facility': 'KLES Dr. Prabhakar Kore Hospital & Medical Research Center', 'geoPoint': {'lat': 13.06444, 'lon': 80.28056}}, {'city': 'Sūrat', 'country': 'India', 'facility': 'Unity Hospital', 'geoPoint': {'lat': 31.39868, 'lon': 77.14969}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Santi Paolo e Carlo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Fatebenefratelli Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria L. Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliere Universitaria Federico I', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Bolesławiec', 'country': 'Poland', 'facility': 'ZOZ w Boleslawcu', 'geoPoint': {'lat': 51.26418, 'lon': 15.5697}}, {'city': 'Koszalin', 'country': 'Poland', 'facility': 'Nicolaus Copernicus Hospital', 'geoPoint': {'lat': 54.19438, 'lon': 16.17222}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Regional Specialist Hospital', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Global Clinical Trials', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Benoni', 'country': 'South Africa', 'facility': 'Lakeview Hospital', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Synapta Clinical Research, 704 Durban Medical Centre', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Helen Joseph Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Three Rivers', 'country': 'South Africa', 'facility': 'FCRN Clinical Trials Centre', 'geoPoint': {'lat': -26.65406, 'lon': 27.97621}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante Dr. Balmis', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Complejo Asistencial Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Río Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Eike C. Buss, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Apogenix AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apogenix GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}