Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06928051
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of S-892216 in Participants With COVID-19
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in SARS-CoV-2 Viral RNA Level on Day 4 as Assessed by Quantitative Reverse-transcription Polymerase Chain Reaction (qRT-PCR) of Nasopharyngeal (NP) Swabs', 'timeFrame': 'Baseline through Day 4'}], 'secondaryOutcomes': [{'measure': 'Time to the First Negative SARS CoV-2 Viral RNA qRT-PCR Result', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Time to the First SARS CoV-2 Viral RNA Viral RNA Level Less Than the Lower Limit of Quantitation (LLOQ)', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Number of Participants With a Positive SARS CoV-2 Viral RNA qRT-PCR Test', 'timeFrame': 'Baseline, Days 2, 4, 6, 10, 14, 21, and 28'}, {'measure': 'Change From Baseline in SARS CoV-2 Viral RNA Level', 'timeFrame': 'Baseline, Days 2, 6, 10, 14, 21, and 28'}, {'measure': 'Area Under the Curve of Change From Baseline in SARS-CoV-2 Viral RNA Level Through Day 4 and Day 6', 'timeFrame': 'Baseline through Day 4 and Day 6'}, {'measure': 'Time to Sustained (2 Consecutive Days) Resolution of COVID-19 Symptoms', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Time to First Resolution of COVID-19 Symptoms', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Time to Return to Pre-COVID-19 Health', 'timeFrame': 'Baseline through Day 28'}, {'measure': 'Plasma Concentration of S-892216', 'timeFrame': 'Days 2, 6, and 10'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S-892216', 'Mpro', 'Main Protease', 'Nonstructural Protein 5', 'nsp5', 'Protease Inhibitor'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Must weigh ≥40 kilograms\n* Must have at least 2 COVID-19 signs/symptoms of mild or higher severity, or at least 1 sign/symptom of moderate or higher severity, within the 72 hours prior to randomization, and the symptoms must still be present in the 24 hours prior to randomization\n* Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, qRT-PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva), or any other SARS-CoV-2 test approved according to local regulations, collected ≤72 hours (3 days) prior to randomization\n* Oxygen saturation (SpO2) of ≥92% on room air adjusted for altitude and obtained at rest by study staff within the 24 hours prior to randomization. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, SpO2 measured while on standard home oxygen supplementation level must be ≥92%.\n* Capable and willing to complete an electronic participant diary\n* Contraceptive use by female participants should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Note: The investigational medication may lead to an increase or decrease of sex hormone levels; therefore, hormonal contraception must not be used alone and must be combined with a barrier method.\n* A woman of childbearing potential must have a negative urine pregnancy test within the 24 hours before the first dose of investigational intervention\n* Must be randomized ≤72 hours from onset of COVID-19 symptoms (defined as the time point when at least 1 of the COVID-19 symptoms occurs)\n* Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period unless meeting hospitalization criteria or reaching Day 28, whichever is earliest\n\nKey Exclusion Criteria:\n\n* High risk of progression to severe COVID-19, as defined in the protocol\n* Documented respiratory infection (for example, influenza, respiratory syncytial virus) other than COVID-19 within the 14 days prior to the screening visit\n* Known current renal impairment defined as estimated glomerular filtration rate \\<60 milliliters/minute/1.73 meters squared or requiring dialysis\n* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy)\n* Known history of any of the following abnormalities in the following clinical laboratory tests (within the 6 months prior to the screening visit):\n\n * Total bilirubin ≥2 × upper limit of normal (ULN) (except for Gilbert's syndrome)\n * Aspartate aminotransferase or alanine aminotransferase ≥2 × ULN\n* A QT interval corrected using Fridericia's formula at the screening visit:\n\n * For males: \\>450 milliseconds (msec)\n * For females: \\>470 msec\n* History of hospitalization for the current SARS-CoV-2 infection or anticipated need for hospitalization within 24 hours after randomization\n* History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Women with a history of osteoporosis\n* Received or expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study through day 28\n* Received or expected to receive any other COVID-19-specific treatment, including outpatient remdesivir, Paxlovid, molnupiravir, monoclonal antibodies, ensitrelvir, and convalescent plasma for the current COVID-19 infection\n* Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the screening visit\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06928051', 'briefTitle': 'A Study of S-892216 in Participants With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'Phase 2 Study of S-892216 in Participants Infected With SARS-CoV-2', 'orgStudyIdInfo': {'id': '2314T1621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-892216: Dose 1', 'description': 'Participants will receive S-892216.', 'interventionNames': ['Drug: S-892216', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'S-892216: Dose 2', 'description': 'Participants will receive S-892216.', 'interventionNames': ['Drug: S-892216']}, {'type': 'EXPERIMENTAL', 'label': 'S-892216: Dose 3', 'description': 'Participants will receive S-892216.', 'interventionNames': ['Drug: S-892216']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'S-892216', 'type': 'DRUG', 'description': 'S-892216 will be administered orally as a tablet.', 'armGroupLabels': ['S-892216: Dose 1', 'S-892216: Dose 2', 'S-892216: Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered orally as a tablet.', 'armGroupLabels': ['Placebo', 'S-892216: Dose 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Healthstar Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '33073', 'city': 'Coconut Creek', 'state': 'Florida', 'country': 'United States', 'facility': 'Invictus Clinical Research Group LLC', 'geoPoint': {'lat': 26.25175, 'lon': -80.17894}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Hope Clinical Trials', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '34142', 'city': 'Immokalee', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research for Health Improvement LLC', 'geoPoint': {'lat': 26.41869, 'lon': -81.4173}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LCC Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'CCM Clinical Research Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Health Clinical Trials', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Continental Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Entrust Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33185', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Kendall South Medical Center Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Springs Community Health Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Quality Research of South Florida', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33144', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Oceane7 Medical & Research Center, Inc.', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32807', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Combined Research Orlando Phase I-IV LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Clinical Professionals', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Balanced Life Health Care Solutions', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '78520', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'PanAmerican Clincal Research', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '75209', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Alina Clinical Trials LLC', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75126', 'city': 'Forney', 'state': 'Texas', 'country': 'United States', 'facility': 'Care United Research, LLC', 'geoPoint': {'lat': 32.74818, 'lon': -96.47193}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Partners LLC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '26537', 'city': 'Kingwood', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Frontier Clinical Research LLC', 'geoPoint': {'lat': 39.47176, 'lon': -79.68339}}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 10'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 11'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 12'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 13'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 14'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 15'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 16'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 17'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 18'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 19'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 1'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 20'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 21'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 22'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 23'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 24'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 25'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 26'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 27'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 28'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 29'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 2'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 30'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 31'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 32'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 33'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 34'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 35'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 36'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 3'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 4'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 5'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 6'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 7'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 8'}, {'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japanese Site 9'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}