Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-27 @ 8:13 AM
Study NCT ID:
NCT04380532
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tableted COVID-19 Therapeutic Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy volunteers'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on CBC as per CTCAE v4.0', 'timeFrame': '15 Days', 'description': 'Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods'}, {'measure': 'Effect on biochemistry parameters as per CTCAE v4.0', 'timeFrame': '15 Days', 'description': 'Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer'}], 'secondaryOutcomes': [{'measure': 'Lack of adverse events as per CTCAE v4.0', 'timeFrame': '15 days', 'description': 'Clinical well-being assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'SARS-CoV-2', 'coronavirus', 'respiratory disease', 'SARS', 'ARDS', 'pneumonia', 'pandemic'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '17683247', 'type': 'BACKGROUND', 'citation': 'Silin DS, Lyubomska OV, Jirathitikal V, Bourinbaiar AS. Oral vaccination: where we are? Expert Opin Drug Deliv. 2007 Jul;4(4):323-40. doi: 10.1517/17425247.4.4.323.'}]}, 'descriptionModule': {'briefSummary': 'Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.', 'detailedDescription': 'Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)\n* Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)\n\nExclusion Criteria:\n\n* Unable to take oral medication,\n* Immunocompromised\n* Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,\n* BMI less than 18\n* Smoking history (more than one pack per day)'}, 'identificationModule': {'nctId': 'NCT04380532', 'acronym': 'COVID-19', 'briefTitle': 'Tableted COVID-19 Therapeutic Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunitor LLC'}, 'officialTitle': 'Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill', 'orgStudyIdInfo': {'id': 'Imm24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-SARS recipients', 'description': 'Single arm having at least 20 volunteers administered once-per-day pill of V-SARS', 'interventionNames': ['Biological: V-SARS']}], 'interventions': [{'name': 'V-SARS', 'type': 'BIOLOGICAL', 'description': 'Therapeutic vaccine formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunters for at least one month', 'armGroupLabels': ['V-SARS recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6K 2G8', 'city': 'Vancouver', 'state': 'BC - British Columbia', 'country': 'Canada', 'facility': 'Immunitor Inc', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '13381', 'city': 'Ulaanbaatar', 'state': 'BZD, 3-khoroo', 'country': 'Mongolia', 'facility': 'Aldar Bourinbayar', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'overallOfficials': [{'name': 'Aldar Bourinbayar, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunitor LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://immunitor.com', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'when become public', 'ipdSharing': 'YES', 'description': 'Free dissemination of published data', 'accessCriteria': 'non-confidential data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunitor LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Immunitor Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}