Ultra Low Doses of Therapy With Radiation Applicated to COVID-19
NCT ID: NCT04394182
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
15 participants
INTERVENTIONAL
2020-04-21
2022-03-21
Brief Summary
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In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose \< 1 Gy.
The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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An experimental group receiving radiotherapy
an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)
Ultra-Low-dose radiotherapy
The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.
ventilatory support with oxygen therapy
Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
Lopinavir/ritonavir
100/400 mg/12h; 7-10 days
Hydroxychloroquine
200 mg/12h
Azithromycin
500 mg/24h, 3 days
Piperacillin/tazobactam
4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function
Low molecular weight heparin
prophylactic doses
Corticosteroid injection
250mg x 3 boluses
Tocilizumab
600mg single dose
Interventions
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Ultra-Low-dose radiotherapy
The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.
ventilatory support with oxygen therapy
Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
Lopinavir/ritonavir
100/400 mg/12h; 7-10 days
Hydroxychloroquine
200 mg/12h
Azithromycin
500 mg/24h, 3 days
Piperacillin/tazobactam
4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function
Low molecular weight heparin
prophylactic doses
Corticosteroid injection
250mg x 3 boluses
Tocilizumab
600mg single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
3. Charlson Comorbidity Index (CCI) less than 6 score.
4. Poor or no response to standard medical treatment, based on:
\*% Sat02 \<93%
* Oxygen therapy escalation (Understanding from less to more need for support: Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)
* Pa02 / Fi02 (blood gas analysis) \<300 mmHg
* 1 or more inflammatory and immunological analytical parameters such as lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen with values above the normal range, except lymphocytes.
* Radiological impairment defined as worsening of TSS throughout admission or score at admission: TSS\> 5 by a diagnostic baseline CT scan.
5. Eastern Cooperative Oncology Group (ECOG) Status \< or = 3
6. Life expectancy (LE)\> 1 month at hospital admission for COVID-19
7. No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).
8. Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.
* Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.
* Patients admitted in ICU.
* Refusal of treatment after verbal information.
18 Years
120 Years
ALL
No
Sponsors
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Hospital La Milagrosa
UNKNOWN
Hospital Vithas Valencia Consuelo
UNKNOWN
Fundacion GenesisCare
NETWORK
Responsible Party
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Principal Investigators
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Escarlata López Ramírez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundacion GenesisCare
Locations
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Hospital La Milagrosa, GenesisCare
Madrid, , Spain
Hospital Vithas Valencia Consuelo
Valencia, , Spain
Countries
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References
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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.
Berk LB, Hodes PJ. Roentgen therapy for infections: an historical review. Yale J Biol Med. 1991 Mar-Apr;64(2):155-65.
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.
Cuttler JM. Application of Low Doses of Ionizing Radiation in Medical Therapies. Dose Response. 2020 Jan 6;18(1):1559325819895739. doi: 10.1177/1559325819895739. eCollection 2020 Jan-Mar.
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.
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.
Rodel F, Keilholz L, Herrmann M, Sauer R, Hildebrandt G. Radiobiological mechanisms in inflammatory diseases of low-dose radiation therapy. Int J Radiat Biol. 2007 Jun;83(6):357-66. doi: 10.1080/09553000701317358.
Schaue D, Jahns J, Hildebrandt G, Trott KR. Radiation treatment of acute inflammation in mice. Int J Radiat Biol. 2005 Sep;81(9):657-67. doi: 10.1080/09553000500385556.
Torres Royo L, Antelo Redondo G, Arquez Pianetta M, Arenas Prat M. Low-Dose radiation therapy for benign pathologies. Rep Pract Oncol Radiother. 2020 Mar-Apr;25(2):250-254. doi: 10.1016/j.rpor.2020.02.004. Epub 2020 Feb 22.
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.
Moreno-Olmedo E, Suarez-Gironzini V, Perez M, Filigheddu T, Minguez C, Sanjuan-Sanjuan A, Gonzalez JA, Rivas D, Gorospe L, Larrea L, Lopez E. COVID-19 pneumonia treated with ultra-low doses of radiotherapy (ULTRA-COVID study): a single institution report of two cases. Strahlenther Onkol. 2021 May;197(5):429-437. doi: 10.1007/s00066-020-01743-4. Epub 2021 Jan 27.
Related Links
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Li, K., Fang, Y., Li, W. et al. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol (2020). https://doi.org/10.1007/s00330-020-06817-6
Other Identifiers
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20.4.1597-GHM
Identifier Type: -
Identifier Source: org_study_id
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