Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis (COVRTE-19)
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|ClinicalTrials.gov Identifier: NCT04414293|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : July 31, 2020
The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU
|Condition or disease||Intervention/treatment||Phase|
|COVID Pneumonia, Viral||Radiation: Lung Low Dose Radiation||Not Applicable|
The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".
Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.
Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.
The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.
This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
All the patients will be treated with low dose lung radiation
Radiation: Lung Low Dose Radiation
The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
- blood oxygen saturation level [ Time Frame: 48 hours ]Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
- Torax X-ray [ Time Frame: 48 hours ]radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
- Hospitalization [ Time Frame: 2 months ]number of days of hospital stay.
- days free of assisted mechanical respiration [ Time Frame: 3 month ]Number of days free of assisted mechanical respiration.
- Mortality [ Time Frame: 3 months ]number of deaths
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414293
|Contact: Francisco Garcia Piñón, MScfirstname.lastname@example.org|
|Hospital Provincial de Castellon|
|Castellón De La Plana, Castellon, Spain, 12002|
|Principal Investigator:||Carlos Ferrer Albiach, MD||Hospital Provincial de Castellon|