Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04771351
Status:
WITHDRAWN
Last Update Posted:
2022-08-16
First Post:
2021-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000714227', 'term': 'STI-2020'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'A different study will be conducted.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who are alive and free of respiratory failure at Day 29', 'timeFrame': 'Baseline through Day 29', 'description': 'Proportion of subjects who are alive and free of respiratory failure at Day 29'}], 'secondaryOutcomes': [{'measure': 'Viral load reduction', 'timeFrame': 'Baseline to Day 4, 15, and 29', 'description': 'Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test'}, {'measure': 'Time to sustained clinical improvement', 'timeFrame': 'Baseline through Day 29', 'description': 'Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29'}, {'measure': 'Proportion of subjects with clinical improvement', 'timeFrame': 'Baseline to Day 15 and 29', 'description': 'Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29'}, {'measure': 'All-cause mortality at Day 29', 'timeFrame': 'Baseline through Day 29', 'description': 'All-cause mortality at Day 29'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.', 'detailedDescription': 'This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive for COVID-19 by an approved antigen test\n* Progressive disease suggestive of ongoing COVID-19 infection\n* Requires hospitalization for acute medical care\n* Provides written informed consent\n* Willing to follow contraception guidelines during study\n\nExclusion Criteria:\n\n* Requires high-flow oxygen supplementation\n* Current or imminent respiratory failure\n* Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours\n* Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments\n* Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)\n* Pregnant or lactating and breast feeding, or planning on either during the study\n* Unable to comply with planned study procedures and be available for all follow-up visits"}, 'identificationModule': {'nctId': 'NCT04771351', 'briefTitle': 'Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorrento Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19', 'orgStudyIdInfo': {'id': 'AMG-COV-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVI-AMG 100 mg', 'description': 'A single injection of 100 mg of COVI-AMG will be administered.', 'interventionNames': ['Biological: COVI-AMG']}, {'type': 'EXPERIMENTAL', 'label': 'COVI-AMG 200 mg', 'description': 'A single injection of 200 mg of COVI-AMG will be administered.', 'interventionNames': ['Biological: COVI-AMG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single injection of placebo will be administered.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'COVI-AMG', 'type': 'BIOLOGICAL', 'otherNames': ['STI-2020'], 'description': 'COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)', 'armGroupLabels': ['COVI-AMG 100 mg', 'COVI-AMG 200 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Diluent solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Teradan Clinical Trials', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}], 'overallOfficials': [{'name': 'Mike Royal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorrento Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorrento Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}