Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT04493294
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'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': '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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'One year', 'description': 'Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'One year', 'description': 'Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'One year', 'description': 'Duration of hospitalization for the whole group and different groups with or without oxygen requirement'}, {'measure': 'Time to recovery', 'timeFrame': 'One month', 'description': 'Ordinal scale at the time of radiotherapy and 28 days later'}, {'measure': 'Oxygen saturation rate', 'timeFrame': 'One year', 'description': 'Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy'}, {'measure': 'Patient inflammatory status', 'timeFrame': 'One year', 'description': 'Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'pneumonitis', 'whole lung radiotherapy', 'low dose'], 'conditions': ['COVID-19 Pneumonitis']}, 'referencesModule': {'references': [{'pmid': '32373721', 'type': 'BACKGROUND', 'citation': 'Lara PC, Burgos J, Macias D. Low dose lung radiotherapy for COVID-19 pneumonia. The rationale for a cost-effective anti-inflammatory treatment. Clin Transl Radiat Oncol. 2020 Apr 25;23:27-29. doi: 10.1016/j.ctro.2020.04.006. eCollection 2020 Jul.'}, {'pmid': '32489696', 'type': 'BACKGROUND', 'citation': 'Lara PC, Nguyen NP, Macias-Verde D, Burgos-Burgos J, Arenas M, Zamagni A, Vinh-Hung V, Baumert BG, Motta M, Myint AS, Bonet M, Popescu T, Vuong T, Appalanaido GK, Trigo L, Karlsson U, Thariat J. Whole-lung Low Dose Irradiation for SARS-Cov2 Induced Pneumonia in the Geriatric Population: An Old Effective Treatment for a New Disease? Recommendation of the International Geriatric Radiotherapy Group. Aging Dis. 2020 May 9;11(3):489-493. doi: 10.14336/AD.2020.0506. eCollection 2020 May.'}]}, 'descriptionModule': {'briefSummary': 'Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis', 'detailedDescription': 'Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.\n\nEven though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.\n\nMethods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.\n\nDiscussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen\n\nExclusion Criteria:\n\n* Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial'}, 'identificationModule': {'nctId': 'NCT04493294', 'briefTitle': 'Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis', 'organization': {'class': 'OTHER', 'fullName': 'International Geriatric Radiotherapy Group'}, 'officialTitle': 'Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group', 'orgStudyIdInfo': {'id': 'IGRG01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis', 'type': 'RADIATION', 'description': 'Low dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nam p Nguyen, MD', 'role': 'CONTACT', 'email': 'namphong.nguyen@yahoo.com', 'phone': '202-865-1421'}], 'overallOfficials': [{'name': 'Brigitta G Baumert, M.D.Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There are over 40 people involved in the study, we need their approval before data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Geriatric Radiotherapy Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brigitta G. Baumert', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Nam Nguyen', 'investigatorAffiliation': 'International Geriatric Radiotherapy Group'}}}}