Clinical trial · Interventional
Ultra Low Doses of Therapy With Radiation Applicated to COVID-19
Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers
NCT04394182CI-TRIAL-00057394ULTRA-COVIDsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytokine Storm | — | UNRESOLVED | — |
| Pneumonia, Viral | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azithromycin | Drug | — | UNRESOLVED |
| Corticosteroid injection | Drug | — | UNRESOLVED |
| Hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
| Lopinavir/ritonavir | Drug | — | UNRESOLVED |
| Low molecular weight heparin | Drug | — | UNRESOLVED |
| Piperacillin/tazobactam | Drug | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
| Ultra-Low-dose radiotherapy | Radiation | — | UNRESOLVED |
| ventilatory support with oxygen therapy |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- An experimental group receiving radiotherapy
- description
- 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)
- interventionNames
- Radiation: Ultra-Low-dose radiotherapy
- Device: ventilatory support with oxygen therapy
- Drug: Lopinavir/ritonavir
- Drug: Hydroxychloroquine
- Drug: Azithromycin
- Drug: Piperacillin/tazobactam
- Drug: Low molecular weight heparin
- Drug: Corticosteroid injection
- Drug: Tocilizumab
Primary outcomes (2)
- measure
- Oxygen Therapy Status at Day 2
- timeFrame
- At 2 after RT
- description
- To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir \>VMK \>Nasal Cannula-(NC).)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years-old. 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. Exclusion Criteria: * Failure to meet the inclusion criteria. * 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.
References
Publications (11)
- RESULTKirkby 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 32342871
- RESULTBerk LB, Hodes PJ. Roentgen therapy for infections: an historical review. Yale J Biol Med. 1991 Mar-Apr;64(2):155-65. PMID 1750226
- RESULTCalabrese 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 24348219
- RESULTCuttler 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. PMID 31933547
- RESULTArenas 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 22907572
- RESULTCalabrese 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 31060383
- RESULTRodel 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. PMID 17487675
- RESULTSchaue 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.