Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 PM
Study NCT ID:
NCT04734860
Status:
WITHDRAWN
Last Update Posted:
2022-02-25
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', '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'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'A different study will be conducted.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who have remained out of the hospital or emergency room through Day 29', 'timeFrame': 'Randomization to Day 29', 'description': 'Proportion of subjects who have remained out of the hospital or emergency room through Day 29'}], 'secondaryOutcomes': [{'measure': 'Viral load reduction from baseline to Day 8, 15, 29, 43, and 70', 'timeFrame': 'Randomization to Day 8, 15, 29, 43, 70', 'description': 'Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test'}, {'measure': 'Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70', 'timeFrame': 'Randomization to Day 43 and Day 70', 'description': 'Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70'}, {'measure': 'Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score', 'timeFrame': 'Randomization to Day 15, 29, 43', 'description': 'Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43'}, {'measure': 'Time to resolution of fever', 'timeFrame': 'Randomization through study completion at Day 70', 'description': 'For subjects who have a fever at randomization, time to resolution of the fever'}]}, '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 study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.', 'detailedDescription': 'This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. 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* Mild symptoms consistent with a COVID-19 viral infection\n* Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* Evidence of moderate COVID-19 per FDA severity categorization\n* Pregnant or lactating and breast feeding or planning on either during the study\n* Has a documented infection other than COVID-19\n* Has received a COVID-19 vaccine\n* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT04734860', 'briefTitle': 'Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorrento Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms', 'orgStudyIdInfo': {'id': 'AMG-COV-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVI-AMG', 'description': 'A single injection of 40 mg, 100 mg, or 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']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Diluent solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative NeuroScience Research, LLC', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergy Healthcare LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Med-Care Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'ETNA Medical Center', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}], 'overallOfficials': [{'name': 'Mike Royal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorrento Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorrento Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}