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 possible therapeutic option in these patients. This is a preliminary exploratory study (non-pharmacological interventional) to evaluate the feasibility and tolerability of low-dose radiotherapy treatment of SARS-Cov-2 immune-mediated pneumonia, for the subsequent implementation of a phase II study.This is a preliminary, monocentric, single-arm, interventional, non-pharmacological exploratory study. All enrolled patients will be treated with low-dose radiotherapy. Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy (further details in the dedicated section).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lenght of hospital stay (days)
Timeframe: Six months
2
Number of Intensive Care Unit admissions
Timeframe: Six months
Trial details
NCT IDNCT04377477
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia