Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04390412
Status:
UNKNOWN
Last Update Posted:
2020-11-10
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Dose Radiotherapy in COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline blood oxygenation', 'timeFrame': '28 days', 'description': 'O2 saturation'}, {'measure': 'Number of Hospital stay days', 'timeFrame': '28 days', 'description': 'Total days the patient is admitted to hospital'}, {'measure': 'Number of ICU stay days', 'timeFrame': '28 days', 'description': 'Total days the patient is admitted to ICU'}, {'measure': 'Number of intubation events', 'timeFrame': '28 days', 'description': 'Total number of intubations performed after the treatment'}], 'secondaryOutcomes': [{'measure': 'WBC', 'timeFrame': '28 days', 'description': 'Changes in WBC count if base-line is abnormal'}, {'measure': 'Platelets', 'timeFrame': '28 days', 'description': 'Changes in Platelets count if base-line is abnormal'}, {'measure': 'CRP', 'timeFrame': 'Day 1', 'description': 'Changes in CRP serum level'}, {'measure': 'CRP', 'timeFrame': 'Day 2', 'description': 'Changes in CRP serum level'}, {'measure': 'CRP', 'timeFrame': 'Day 3', 'description': 'Changes in CRP serum level'}, {'measure': 'CRP', 'timeFrame': 'Day 4', 'description': 'Changes in CRP serum level'}, {'measure': 'CRP', 'timeFrame': 'Day 5', 'description': 'Changes in CRP serum level'}, {'measure': 'IL-6', 'timeFrame': 'Day 1', 'description': 'Changes in IL-6 serum level'}, {'measure': 'IL-6', 'timeFrame': 'Day 2', 'description': 'Changes in IL-6 serum level'}, {'measure': 'IL-6', 'timeFrame': 'Day 3', 'description': 'Changes in IL-6 serum level'}, {'measure': 'IL-6', 'timeFrame': 'Day 4', 'description': 'Changes in IL-6 serum level'}, {'measure': 'IL-6', 'timeFrame': 'Day 5', 'description': 'Changes in IL-6 serum level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Dose Lung Radiotherapy', 'COVID-19', 'anti-inflammatory'], 'conditions': ['COVID', 'SARS (Severe Acute Respiratory Syndrome)']}, 'referencesModule': {'references': [{'pmid': '24348219', 'type': 'BACKGROUND', 'citation': 'Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70.'}, {'pmid': '26051282', 'type': 'BACKGROUND', 'citation': 'Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rodel C, Weiss C, Rodel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8.'}, {'type': 'BACKGROUND', 'citation': 'Clayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020'}, {'pmid': '32342871', 'type': 'BACKGROUND', 'citation': 'Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. No abstract available.'}, {'pmid': '32342874', 'type': 'BACKGROUND', 'citation': 'Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Stefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477'}]}, 'descriptionModule': {'briefSummary': 'Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.', 'detailedDescription': "SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.\n\nLow dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.\n\nIn this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.\n\nA total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)\n* Presence of pulmonary involvement ( defined by P/F ratio or NIV need)\n* Less than 3 days since the onset of ARDS\n* Age \\> 60 years\n* ↑ IL-6 ( if available)\n* ↑ CRP\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Inability to transfer to the radiation unit\n* Hemodynamic instability\n* Septic shock and organ dysfunction\n* Severe ARDS P/F ratio ≤ 100 mmHg\n* History of cardiac failure\n* Contraindications to radiation'}, 'identificationModule': {'nctId': 'NCT04390412', 'briefTitle': 'Low Dose Radiotherapy in COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial', 'orgStudyIdInfo': {'id': '23568'}, 'secondaryIdInfos': [{'id': 'IRCT20200509047366N1', 'type': 'REGISTRY', 'domain': 'Iranian Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose Radiotherapy', 'description': '0.5 Gy radiation to both lungs in an AP/PA fashion', 'interventionNames': ['Radiation: Low Dose Radiotherapy']}], 'interventions': [{'name': 'Low Dose Radiotherapy', 'type': 'RADIATION', 'description': '0.5 Gy radiation to both lungs in an AP/PA treatment plan', 'armGroupLabels': ['Low Dose Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Imam Hossein Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ahmad Ameri, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}, {'name': 'Nazanin Rahnama, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the completion of trial for one year.', 'ipdSharing': 'YES', 'description': 'IPD will be shared after the completion of study to other researchers.', 'accessCriteria': 'Verified researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}