COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19)

NCT04377477 | Completed DMC

• 1 other identifier: NP 4097
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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).

Conditions

COVID-19

Keywords

RADIOTHERAPY; PNEUMONITIS

Outcome Measures

Primary Outcomes (2)

• Lenght of hospital stay (days)

  Evaluation of the feasibility of low-dose radiotherapy treatment of SARS-Cov2 pneumonia, for the purpose of the subsequent implementation of a phase II study; lenght of hospital stay will be recorded

  Six months

• Number of Intensive Care Unit admissions

  Evaluation of the feasibility of low-dose radiotherapy treatment of SARS-Cov2 pneumonia; the number of intensive care unit admissions will be recorded

  Six months

Secondary Outcomes (3)

• Variation of the Brescia COVID-19 Respiratory Severity Scale after treatment

  3, 6 and 10 days

• Occurence of CTCAE 5.0 adverse events

  10 days and 6 months

• Variation of the chest X-ray radiological findings according to Brixia scoring system

  3 and 6 days

Study Arms (1)

Lung low dose radiotherapy

EXPERIMENTAL

Irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy

Radiation: Single fraction whole lung radiotherapy

Interventions

Single fraction whole lung radiotherapy RADIATION

Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy

Lung low dose radiotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Radiation Oncology Department, ASST SpedaliCivili, Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stefano M Magrini, Prof

  Brescia University - ASST Spedali Civili Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: May 10, 2020
• Primary Completion: March 10, 2022
• Study Completion: May 30, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available starting six months from the publication and for five years.
• Access Criteria: Written request to principal investigator , indicating the details of the data requested, the reasons of the inquiry and the purpose of the data use; data will be released after Local Ethics Committee approval. Data will be released only for no-profit use, in particular for research purposes.

Locations

IT (1)