Pneumonia, ViralULTRA-COVIDNCT04394182
Ultra Low Doses of Therapy With Radiation Applicated to COVID-19
A study testing Ultra-Low-dose radiotherapy, ventilatory support with oxygen therapy and Lopinavir/ritonavir in people with Pneumonia, Viral and Cytokine Storm, run by Fundacion GenesisCare at 2 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pneumonia, Viral, Cytokine Storm
- What is being tested?
- Ultra-Low-dose radiotherapy, ventilatory support with oxygen therapy and Lopinavir/ritonavir
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Apr 2020to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years-old.
- Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
- Charlson Comorbidity Index (CCI) less than 6 score.
- 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)
Show all 13Show fewer
- 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.
- Eastern Cooperative Oncology Group (ECOG) Status < or = 3
- Life expectancy (LE)> 1 month at hospital admission for COVID-19
- No previous thoracic RT (relative-individualization criteria) or chemotherapy (chemoinduced pulmonary toxicity, eg Bleomycin).
- Verbal information on the procedure, objective and secondary effects, acceptance and signing of informed consent by the patient or legal guardian.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital La Milagrosa, GenesisCare
Madrid, 28010
Hospital Vithas Valencia Consuelo
Valencia, 46007
About this study
Official title: Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers
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.
Read the detailed description
The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is proposes a prospective multicenter study. It will include 15 patients, to assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.
- Conditions
- Pneumonia, Viral, Cytokine Storm
- Being tested
- Ultra-Low-dose radiotherapy, ventilatory support with oxygen therapy, Lopinavir/ritonavir, Hydroxychloroquine, Azithromycin
- Keywords
- Low Dose Radiotherapy, COVID19 pneumonia, Anti-inflammatory effects, Acute Respiratory Distress Syndrome (ARDS)
- Medical subject headings
- Pneumonia, Viral, Cytokine Release Syndrome, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-Low-dose radiotherapyRadiation
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 therapyDevice
Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
Lopinavir/ritonavirDrug
Also called Kaletra
100/400 mg/12h; 7-10 days
Also called Dolquine
200 mg/12h
AzithromycinDrug
500 mg/24h, 3 days
Piperacillin/tazobactamDrug
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 heparinDrug
prophylactic doses
Corticosteroid injectionDrug
Also called Urbason
250mg x 3 boluses
TocilizumabDrug
600mg single dose
| Study group | Role | What they receive |
|---|---|---|
| An experimental group receiving radiotherapy | Experimental | 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Therapy Status at Day 2
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).)
Measured: At 2 after RT
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measured: At 2 days after RT
Secondary outcomes (13)
Blood Gas Analysis at Day 2
Pa02 / Fi02 > 300 mmHg
Measured: At 2 days after RT
Blood Test at Day 2
Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measured: At 2 days after RT
Oxygen Therapy Status at Day 5
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).)
Measured: At 5 after RT
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measured: At 5 days after RT
Blood Test at Day 5
Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measured: At 5 days after RT
Oxygen Therapy Status at Day 7
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).)
Measured: At 7 after RT
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measured: At 7 days after RT
Blood Test at Day 7
Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measured: At 7 days after RT
Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7
To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment .
It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point.
NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)
Measured: At 7 days after RT
Recovery time
Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)
Measured: From RT administration until hospital discharge or death
COVID-19 status
COVID-19 negativization test
Measured: At 7 days after RT
Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1
To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment .
It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point.
NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)
Measured: At 1 month after RT
Acute Toxicity
Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.
Measured: 1-3 months after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start21 Apr 2020
- Primary completion31 Dec 2020
- Study completion21 Mar 2022 (estimated)
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- an experimental group will receive ultra low-dose lung radiotherapy
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion GenesisCare
- Sponsor type
- Research network
- Collaborators
- Hospital La Milagrosa, Hospital Vithas Valencia Consuelo
- Responsible party
- Sponsor
- Investigators
- Escarlata López Ramírez, MD, PhD, Principal investigator, Fundacion GenesisCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394182
- Sponsor's protocol ID
- 20.4.1597-GHM
- Acronym
- ULTRA-COVID
- Status last verified
- Mar 2022
- First submitted
- 15 May 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Medical history and biographical and clinical data of each patient will be recorded and shared. The overall results of any research conducted will be available on study data publication.
Publications
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.
PubMed 32342871Berk LB, Hodes PJ. Roentgen therapy for infections: an historical review. Yale J Biol Med. 1991 Mar-Apr;64(2):155-65.
PubMed 1750226Calabrese 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.
PubMed 24348219Cuttler 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.
PubMed 31933547Arenas 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.
PubMed 22907572Calabrese 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.
PubMed 31060383Rodel 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.
PubMed 17487675Schaue 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.
PubMed 16368644Torres 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.
PubMed 32140081Lara 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.
PubMed 32373721Moreno-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.
PubMed 33502567
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers
- ClinicalTrials.gov ID
- NCT04394182
- Acronym / sponsor ID
- ULTRA-COVID / 20.4.1597-GHM
- Conditions
- Pneumonia, Viral, Cytokine Storm
- Keywords
- Low Dose Radiotherapy, COVID19 pneumonia, Anti-inflammatory effects, Acute Respiratory Distress Syndrome (ARDS)
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of recruitment
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundacion GenesisCareResearch network
- Collaborators
- Hospital La Milagrosa, Hospital Vithas Valencia Consuelo
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 21 Mar 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is proposes a prospective multicenter study. It will include 15 patients, to assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- an experimental group will receive ultra low-dose lung radiotherapy
| Arm | Type | Receives |
|---|---|---|
| An experimental group receiving radiotherapy | Experimental | 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: Tocilizumaban 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) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age > 18 years-old.
- Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain reaction (PCR) or highly suspected to be COVID-related.
- Charlson Comorbidity Index (CCI) less than 6 score.
- Poor or no response to standard medical treatment, based on:
- % Sat02 <93%
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-Low-dose radiotherapyThe total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions. | Radiation | An experimental group receiving radiotherapy |
| ventilatory support with oxygen therapyOxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir | Device | An experimental group receiving radiotherapy |
| Lopinavir/ritonavirAlso: Kaletra100/400 mg/12h; 7-10 days | Drug | An experimental group receiving radiotherapy |
| HydroxychloroquineAlso: Dolquine200 mg/12h | Drug | An experimental group receiving radiotherapy |
| Azithromycin500 mg/24h, 3 days | Drug | An experimental group receiving radiotherapy |
| Piperacillin/tazobactam4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function | Drug | An experimental group receiving radiotherapy |
| Low molecular weight heparinprophylactic doses | Drug | An experimental group receiving radiotherapy |
| Corticosteroid injectionAlso: Urbason250mg x 3 boluses | Drug | An experimental group receiving radiotherapy |
| Tocilizumab600mg single dose | Drug | An experimental group receiving radiotherapy |
Primary outcome
Oxygen Therapy Status at Day 2
Time frame: At 2 after RT
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).)
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2
Time frame: At 2 days after RT
To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
13 secondary outcomes
Blood Gas Analysis at Day 2
Time frame: At 2 days after RT
Blood Test at Day 2
Time frame: At 2 days after RT
Oxygen Therapy Status at Day 5
Time frame: At 5 after RT
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5
Time frame: At 5 days after RT
Blood Test at Day 5
Time frame: At 5 days after RT
Oxygen Therapy Status at Day 7
Time frame: At 7 after RT
Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7
Time frame: At 7 days after RT
Blood Test at Day 7
Time frame: At 7 days after RT
Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7
Time frame: At 7 days after RT
Recovery time
Time frame: From RT administration until hospital discharge or death
COVID-19 status
Time frame: At 7 days after RT
Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1
Time frame: At 1 month after RT
Acute Toxicity
Time frame: 1-3 months after RT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Results publication: PubMed 32342871Kirkby 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.
- Results publication: PubMed 1750226Berk LB, Hodes PJ. Roentgen therapy for infections: an historical review. Yale J Biol Med. 1991 Mar-Apr;64(2):155-65.
- Results publication: PubMed 24348219Calabrese 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.
- Results publication: PubMed 31933547Cuttler 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.
- Results publication: PubMed 22907572Arenas 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.
- Results publication: PubMed 31060383Calabrese 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.
- Results publication: PubMed 17487675Rodel 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.
- Results publication: PubMed 16368644Schaue 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.
- Results publication: PubMed 32140081Torres 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.
- Results publication: PubMed 32373721Lara 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.
- Derived from this study: PubMed 33502567Moreno-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.
- 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/s00330-020-06817-6Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Medical history and biographical and clinical data of each patient will be recorded and shared. The overall results of any research conducted will be available on study data publication.
Related trials for Pneumonia, Viral
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Escarlata López Ramírez, MD, PhD principal investigator
Fundacion GenesisCare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-Low-dose radiotherapy, ventilatory support with oxygen therapy and Lopinavir/ritonavir in people with Pneumonia, Viral and Cytokine Storm, run by Fundacion GenesisCare at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Therapy Status at Day 2 (time frame: At 2 after RT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394182, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.