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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UNKNOWN
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2020-05-04
2020-12-31
Brief Summary
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Detailed Description
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Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.
In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.
A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA fashion
Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
Interventions
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Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
Eligibility Criteria
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Inclusion Criteria
* Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
* Less than 3 days since the onset of ARDS
* Age \> 60 years
* ↑ IL-6 ( if available)
* ↑ CRP
Exclusion Criteria
* Inability to transfer to the radiation unit
* Hemodynamic instability
* Septic shock and organ dysfunction
* Severe ARDS P/F ratio ≤ 100 mmHg
* History of cardiac failure
* Contraindications to radiation
60 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Ahmad Ameri, Prof.
Role: STUDY_CHAIR
Shahid Beheshti University of Medical Sciences
Nazanin Rahnama, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Locations
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Imam Hossein Hospital
Tehran, , Iran
Countries
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References
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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.
Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rodel C, Weiss C, Rodel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8.
Clayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020
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.
Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. No abstract available.
Stefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477
Other Identifiers
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IRCT20200509047366N1
Identifier Type: REGISTRY
Identifier Source: secondary_id
23568
Identifier Type: -
Identifier Source: org_study_id