Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
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- STATUS
- Recruiting
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- participants needed
- 106
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- sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
Summary
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.
Main 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.
Description
Study design: This is a prospective multicenter study in 2 phases:
- 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.
- 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.
Details
Condition | Viral pneumonia |
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Age | 18years - 99years |
Treatment | Azithromycin, Low Molecular Weight Heparin, Hydroxychloroquine Sulfate, Low-dose radiotherapy, Ritonavir/lopinavir, Tocilizumab Injection [Actemra], Corticosteroid, Oxygen supply |
Clinical Study Identifier | NCT04380818 |
Sponsor | Grupo de Investigación Clínica en Oncología Radioterapia |
Last Modified on | 16 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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