Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04414293
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood oxygen saturation level', 'timeFrame': '48 hours', 'description': 'Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels'}, {'measure': 'Torax X-ray', 'timeFrame': '48 hours', 'description': 'radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': '2 months', 'description': 'number of days of hospital stay.'}, {'measure': 'days free of assisted mechanical respiration', 'timeFrame': '3 month', 'description': 'Number of days free of assisted mechanical respiration.'}, {'measure': 'Mortality', 'timeFrame': '3 months', 'description': 'number of deaths'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19 pneumonia', 'Low dose Radiotherapy'], 'conditions': ['COVID', 'Pneumonia, Viral']}, 'descriptionModule': {'briefSummary': 'The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.\n\nThe present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU', 'detailedDescription': 'The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".\n\nBeyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.\n\nThoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.\n\nThe goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.\n\nThis therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 65 years old\n* Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:\n\n * Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).\n * Acute respiratory failure expressed by PaO2 / FIO2 \\<300.\n * Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).\n * Patients with ≤8 days from the onset of symptoms.\n\nExclusion Criteria:\n\n* Patient not consent to participate'}, 'identificationModule': {'nctId': 'NCT04414293', 'acronym': 'COVRTE-19', 'briefTitle': 'Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Provincial de Castellon'}, 'officialTitle': 'Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis', 'orgStudyIdInfo': {'id': 'FHPCS-20-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'All the patients will be treated with low dose lung radiation', 'interventionNames': ['Radiation: Lung Low Dose Radiation']}], 'interventions': [{'name': 'Lung Low Dose Radiation', 'type': 'RADIATION', 'description': 'The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12002', 'city': 'Castellon', 'state': 'Castellon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'FRANCISCO GARCIA PINON, MSc', 'role': 'CONTACT', 'phone': '964354458'}, {'name': 'Carlos Ferrer Albiach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Provincial de Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'centralContacts': [{'name': 'Francisco Garcia Piñón, MSc', 'role': 'CONTACT', 'email': 'francisco.garpi@hospitalprovincial.es', 'phone': '964354458'}], 'overallOfficials': [{'name': 'Carlos Ferrer Albiach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Provincial de Castellon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Provincial de Castellon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Carlos Ferrer Albiach', 'investigatorAffiliation': 'Hospital Provincial de Castellon'}}}}