Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis

COVID Clinical Trial

— COVRTE-19  

Official title:

Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414293
• Other study ID #: FHPCS-20-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Hospital Provincial de Castellon
• Contact: Francisco Garcia Piñón, MSc
• Phone: 964354458
• Email: francisco.garpi[@]hospitalprovincial.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients over 65 years old

• Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:

• Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).

• Acute respiratory failure expressed by PaO2 / FIO2 <300.

• Lymphopenia =0.8 × 109 / L (800 lymphocytes / ml).

• Patients with =8 days from the onset of symptoms.

Exclusion Criteria:

• Patient not consent to participate

Related Conditions & MeSH terms

• COVID
• Pneumonia
• Pneumonia, Viral

Intervention

Radiation:
• Lung Low Dose Radiation
The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.

Locations

Country	Name	City	State
Spain	Hospital Provincial de Castellon	Castellón De La Plana	Castellon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Provincial de Castellon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood oxygen saturation level	Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels	48 hours
Primary	Torax X-ray	radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.	48 hours
Secondary	Hospitalization	number of days of hospital stay.	2 months
Secondary	days free of assisted mechanical respiration	Number of days free of assisted mechanical respiration.	3 month
Secondary	Mortality	number of deaths	3 months