Status:
COMPLETED
COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19)
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
COVID-19
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Low-dose radiotherapy treatment delivered to both lungs in patients with immune-related pneumonia following COVID-19 infection is backed up by biological and clinical bases that justify its use as a p...
Detailed Description
BACKGROUND Since the first case of Severe Acute Respiratory Syndrome - Coronavirus - 2 (SARS-CoV-2) infection and its subsequent clinical manifestation (COronaVIrus Disease 19, COVID-19) in the city ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 50 years
- Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL)
- Patient with Brescia Covid Respiratory Severity Scale (BCRSS) score 2-3
- Suggestive picture finding for interstitial pneumonia on chest X-ray and / or chest CT (optional)
- At least 3 of the following laboratory criteria:
- PCR\> 5 times the maximum limit of the normal value
- Ferritin\> 500 ng / ml
- lactate dehydrogenase (LDH) \> 2 times the maximum limit of the normal value
- D-dimer\> 3 times the maximum limit of the normal value
- Aspartate aminotransferase (AST)\> 2 times the maximum limit of the normal value
- Total lymphocytes \<1000 / ml
- Ability to understand and sign informed consent
- Ability to acquire and maintain the set-up necessary for the delivery of radiotherapy treatment
- A negative pregnancy test will be required of patients of childbearing age before starting radiotherapy treatment. Patients with reproductive potential of both sexes will have to agree to use an effective contraceptive method for at least 6 months from the date of treatment.
- Exclusion Criteria:
- Age \<50 years
- Brescia Covid Respiratory Severity Scale (BCRSS) score greater than 3
- Patients undergoing invasive mechanical ventilation
- Patients with active autoimmune systemic diseases
- Patients with active infections that are not responsive to current treatment
- Patients with a positive pregnancy test
- Impossibility to maintain the set-up necessary for radiotherapy treatment
- Other concomitant treatments for COVID-19 do not represent an exclusion criterion, however they must be reported (specifying the starting date and dosage)
Exclusion
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04377477
Start Date
May 10 2020
End Date
May 30 2022
Last Update
August 9 2024
Active Locations (1)
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1
Radiation Oncology Department, ASST SpedaliCivili, Brescia
Brescia, Italy, 25123