Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT04351659
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood from COVID-19 convalescent donors.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate in production of SARS-CoV-2 specific T cells from convalescent donor', 'timeFrame': 'Two weeks (The expected duration of donor participation is 2 weeks)', 'description': 'Success of SARS-CoV-2 specific T cell manufacturing is defined as production of \\>200,000 T cells per donor. The success rate will be summarized descriptively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Coronavirus disease'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.', 'detailedDescription': 'A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.\n\nThe aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.\n\nA minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 to 65\n* Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past\n* Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria\n* Negative test for SARS-CoV-2 currently\n\nExclusion Criteria:\n\n* Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.'}, 'identificationModule': {'nctId': 'NCT04351659', 'briefTitle': 'Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19', 'orgStudyIdInfo': {'id': 'COVID-T 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood donors', 'description': 'Donors who had tested positive for SARS-CoV-2 in the past and have recovered from COVID-19 and are now suitable for blood donation.', 'interventionNames': ['Other: Blood donation from convalescent donor']}], 'interventions': [{'name': 'Blood donation from convalescent donor', 'type': 'OTHER', 'description': 'Donation of 1 unit of blood or leukapheresis', 'armGroupLabels': ['Blood donors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lip Kun Tan', 'role': 'CONTACT'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Yeh Ching Linn', 'role': 'CONTACT'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Michaela Seng', 'role': 'CONTACT', 'email': 'childhoodcancer@kkh.com.sg', 'phone': '82487085'}], 'overallOfficials': [{'name': 'Wing Hang Leung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KK Hospital, SingHealth, Duke-NUS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}