Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04380818
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%', 'timeFrame': 'Day 2 after interventional radiotherapy', 'description': 'To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. .\n\nIn cases of impossibility the SaFiO2 will be determined'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Day 30 and day 90 after interventional radiotherapy', 'description': 'Lung toxicity measured according to CTCAEv5'}, {'measure': 'Change of the radiological image', 'timeFrame': 'Days 7 and day 30 after interventional radiotherapy', 'description': 'Chest CT'}, {'measure': 'Overall mortality', 'timeFrame': 'Day 15 and Day 30 after interventional radiotherapy', 'description': 'Death of any cause'}, {'measure': 'Measure of pro-inflammatory interleukins', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)'}, {'measure': 'Measure of trasforming growth factor (TGF-b)', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'TGF-β (ng/ml)'}, {'measure': 'Measure of tumor necrosis factor alpha (TNF-a)', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'TNF-α (pg/ml)'}, {'measure': 'Determining overexpression of pro-inflammatory selectin', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'Overexpression of L-, E-, and P-selectin'}, {'measure': 'Determining cell adhesion molecules (CAMs)', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'Overexpression of ICAM-1, VCAM'}, {'measure': 'Measure of marker of oxidative stress PON-1', 'timeFrame': 'Days 1, day 4 and day 7 after interventional radiotherapy', 'description': 'PON-1(paraoxonase and arylesterase activity) (IU/ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID 19', 'RADIATION', 'Anti-inflammatory effects'], 'conditions': ['Pneumonia, Viral']}, 'referencesModule': {'references': [{'pmid': '32171193', 'type': 'BACKGROUND', 'citation': 'Conti P, Ronconi G, Caraffa A, Gallenga CE, Ross R, Frydas I, Kritas SK. Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies. J Biol Regul Homeost Agents. 2020 March-April,;34(2):327-331. doi: 10.23812/CONTI-E.'}, {'pmid': '23057008', 'type': 'BACKGROUND', 'citation': 'Rodel F, Frey B, Manda K, Hildebrandt G, Hehlgans S, Keilholz L, Seegenschmiedt MH, Gaipl US, Rodel C. Immunomodulatory properties and molecular effects in inflammatory diseases of low-dose x-irradiation. Front Oncol. 2012 Sep 25;2:120. doi: 10.3389/fonc.2012.00120. eCollection 2012.'}, {'pmid': '22907572', 'type': 'BACKGROUND', 'citation': 'Arenas M, Sabater S, Hernandez V, Rovirosa A, Lara PC, Biete A, Panes J. Anti-inflammatory effects of low-dose radiotherapy. Indications, dose, and radiobiological mechanisms involved. Strahlenther Onkol. 2012 Nov;188(11):975-81. doi: 10.1007/s00066-012-0170-8. Epub 2012 Aug 22.'}, {'pmid': '18031855', 'type': 'BACKGROUND', 'citation': 'Arenas M, Gil F, Gironella M, Hernandez V, Biete A, Pique JM, Panes J. Time course of anti-inflammatory effect of low-dose radiotherapy: correlation with TGF-beta(1) expression. Radiother Oncol. 2008 Mar;86(3):399-406. doi: 10.1016/j.radonc.2007.10.032. Epub 2007 Nov 26.'}, {'pmid': '22545750', 'type': 'BACKGROUND', 'citation': 'Lodermann B, Wunderlich R, Frey S, Schorn C, Stangl S, Rodel F, Keilholz L, Fietkau R, Gaipl US, Frey B. Low dose ionising radiation leads to a NF-kappaB dependent decreased secretion of active IL-1beta by activated macrophages with a discontinuous dose-dependency. Int J Radiat Biol. 2012 Oct;88(10):727-34. doi: 10.3109/09553002.2012.689464. Epub 2012 May 22.'}, {'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': '31060383', 'type': 'BACKGROUND', 'citation': 'Calabrese EJ, Dhawan G, Kapoor R, Kozumbo WJ. Radiotherapy treatment of human inflammatory diseases and conditions: Optimal dose. Hum Exp Toxicol. 2019 Aug;38(8):888-898. doi: 10.1177/0960327119846925. Epub 2019 May 6.'}, {'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.'}, {'type': 'BACKGROUND', 'citation': "Jean-Marc Cosset, Éric Deutsch, Louis Bazire, Jean-Jacques Mazeron, Cyrus Chargari, Irradiation pulmonaire à faible dose pour l'orage de cytokines du covid-19: pourquoi pas?, Cancer/Radiothérapie, 2020, , ISSN 1278-3218, https://doi.org/10.1016/j.canrad.2020.04.003."}, {'pmid': '32437820', 'type': 'BACKGROUND', 'citation': 'Dhawan G, Kapoor R, Dhawan R, Singh R, Monga B, Giordano J, Calabrese EJ. Low dose radiation therapy as a potential life saving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiother Oncol. 2020 Jun;147:212-216. doi: 10.1016/j.radonc.2020.05.002. Epub 2020 May 8.'}, {'pmid': '32613089', 'type': 'DERIVED', 'citation': 'Algara M, Arenas M, Marin J, Vallverdu I, Fernandez-Leton P, Villar J, Fabrer G, Rubio C, Montero A. Low dose anti-inflammatory radiotherapy for the treatment of pneumonia by covid-19: A proposal for a multi-centric prospective trial. Clin Transl Radiat Oncol. 2020 Jun 15;24:29-33. doi: 10.1016/j.ctro.2020.06.005. eCollection 2020 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients.\n\nMain objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.', 'detailedDescription': 'Study design: This is a prospective multicenter study in 2 phases:\n\n1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued.\n2. Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years old\n* Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses\n* PAFIO2 of less than 300 mmHg or SaFI02 \\<315 mmHg\n* Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.\n* One of the following conditions:\n\n * or IL6 greater than 40\n * or PCR\\> 100mg / l\n\n * D-dimer greater than 1500ng / ml\n * Suspected cytokine release syndrome\n* Have read the information sheet and signed the informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Failure to meet the inclusion criteria\n* Leukopenia \\<1000\n* Pregnancy\n* Not understanding or refusing the purpose of the study'}, 'identificationModule': {'nctId': 'NCT04380818', 'briefTitle': 'Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Investigación Clínica en Oncología Radioterapia'}, 'officialTitle': 'Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study', 'orgStudyIdInfo': {'id': 'IPACOVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'a control group only receive pharmacological treatment', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate', 'Drug: Ritonavir/lopinavir', 'Drug: Tocilizumab Injection [Actemra]', 'Drug: Azithromycin', 'Drug: Corticosteroid', 'Drug: Low molecular weight heparin', 'Device: Oxygen supply']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'an experimental group will receive low-dose lung irradiation', 'interventionNames': ['Radiation: Low-dose radiotherapy', 'Drug: Hydroxychloroquine Sulfate', 'Drug: Ritonavir/lopinavir', 'Drug: Tocilizumab Injection [Actemra]', 'Drug: Azithromycin', 'Drug: Corticosteroid', 'Drug: Low molecular weight heparin', 'Device: Oxygen supply']}], 'interventions': [{'name': 'Low-dose radiotherapy', 'type': 'RADIATION', 'description': 'Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later', 'armGroupLabels': ['Experimental group']}, {'name': 'Hydroxychloroquine Sulfate', 'type': 'DRUG', 'otherNames': ['Dolquine'], 'description': '200 mg/12h for 5 days', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Ritonavir/lopinavir', 'type': 'DRUG', 'otherNames': ['Kaletra'], 'description': '400/100 mg/12h for 7-10 days', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Tocilizumab Injection [Actemra]', 'type': 'DRUG', 'otherNames': ['Actemra'], 'description': '600 mg/day for 1-2 doses', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': '500 mg/24h for 3 days', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Corticosteroid', 'type': 'DRUG', 'description': 'Corticosteroids (methylprednisolone/dexamethasone/prednisone)', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Low molecular weight heparin', 'type': 'DRUG', 'description': 'low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Oxygen supply', 'type': 'DEVICE', 'description': 'Oxygen', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MERITXELL ARENAS, MD, PhD', 'role': 'CONTACT', 'email': 'meritxell.arenas@gmail.com'}], 'facility': 'Hospital Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MANEL ALGARA, MD, PhD', 'role': 'CONTACT', 'email': 'MAlgara@parcdesalutmar.cat'}], 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Angel Montero, MD, PhD', 'role': 'CONTACT', 'email': 'amontero@hmhospitales.com', 'phone': '+34915629949'}], 'facility': 'Hospital Universitario Madrid Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'ANGEL MONTERO, Md, PhD', 'role': 'CONTACT', 'email': 'angel.monteroluis@gmail.com', 'phone': '+34667767601'}], 'overallOfficials': [{'name': 'Angel Montero, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Madrid Sanchinarro'}, {'name': 'Manel Algara, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Mar'}, {'name': 'Merirxell Arenas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Sant Joan de Reus'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Protocol/ICF from approval Individual epidemiological and clinical data after recruitment is complete.', 'ipdSharing': 'YES', 'description': 'Individual epidemiological and clinical data will be shared after recruitment is complete.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Investigación Clínica en Oncología Radioterapia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Madrid Sanchinarro', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Hospital Universitari Sant Joan de Reus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}