Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT04906694
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who have COVID-19-related visit or hospitalization', 'timeFrame': 'Baseline through Day 29', 'description': 'Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29', 'timeFrame': 'Baseline through Day 29', 'description': 'Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29'}, {'measure': 'Viral load change from baseline to D8', 'timeFrame': 'Baseline to Day 8', 'description': 'Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)'}, {'measure': 'Change in WHO Clinical Progression Scale score', 'timeFrame': 'Baseline to Day 8 and Day 29', 'description': 'Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)'}, {'measure': 'Viral load change from baseline to D29', 'timeFrame': 'Baseline to Day 29', 'description': 'Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.', 'detailedDescription': 'Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment\n* Either have no COVID-19 symptoms (asymptomatic) or mild symptoms\n* Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol\n* Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)\n* Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process.\n* Has a documented infection other than COVID-19\n* Pregnant or lactating women who are breast feeding or planning on either during the study\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\n* Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html)\n* Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection."}, 'identificationModule': {'nctId': 'NCT04906694', 'briefTitle': 'Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorrento Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19', 'orgStudyIdInfo': {'id': 'DRP-COV-201US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVI-DROPS', 'description': '10, 20, or 40 mg of COVI-DROPS administered intranasally', 'interventionNames': ['Biological: COVI-DROPS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 mL administered intranasally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'COVI-DROPS', 'type': 'BIOLOGICAL', 'otherNames': ['STI-2099'], 'description': 'COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2', 'armGroupLabels': ['COVI-DROPS']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Diluent solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Future Innovative Treatments, LLC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience dba CNS Healthcare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Med-Care Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions Healthcare', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site Partners, Inc', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30269', 'city': 'Peachtree City', 'state': 'Georgia', 'country': 'United States', 'facility': 'Randomize Now', 'geoPoint': {'lat': 33.39678, 'lon': -84.59576}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Revival Research Institute', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Quality Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Remington Davis', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97030', 'city': 'Gresham', 'state': 'Oregon', 'country': 'United States', 'facility': 'Cyn3rgy Research', 'geoPoint': {'lat': 45.49818, 'lon': -122.43148}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'WR-ClinSearch', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78628', 'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Medical Trials', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}, {'zip': '76051', 'city': 'Grapevine', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Comprehensive Clinical Research Solutions', 'geoPoint': {'lat': 32.93429, 'lon': -97.07807}}, {'zip': '77062', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies Inc. Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77584', 'city': 'Pearland', 'state': 'Texas', 'country': 'United States', 'facility': 'LinQ', 'geoPoint': {'lat': 29.56357, 'lon': -95.28605}}, {'zip': '75154', 'city': 'Red Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Epic Research', 'geoPoint': {'lat': 32.51764, 'lon': -96.80444}}, {'zip': '24501', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Infectious Diseases Associates of Central Virginia', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'Mike Royal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sorrento Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorrento Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}