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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377477
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Stefano Maria Magrini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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).

Condition or disease Intervention/treatment Phase
COVID-19 Radiation: Single fraction whole lung radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Feasibility of Low Dose Radiotherapy for SARS-Cov-2 Pneumonitis (COVID-19 Low Dose Radiotherapy - COLOR 19)
Actual Study Start Date : May 10, 2020
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Lung low dose radiotherapy
Irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy
Radiation: Single fraction whole lung radiotherapy
Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy




Primary Outcome Measures :
  1. Lenght of hospital stay (days) [ Time Frame: Six months ]
    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

  2. Number of Intensive Care Unit admissions [ Time Frame: Six months ]
    Evaluation of the feasibility of low-dose radiotherapy treatment of SARS-Cov2 pneumonia; the number of intensive care unit admissions will be recorded


Secondary Outcome Measures :
  1. Variation of the Brescia COVID-19 Respiratory Severity Scale after treatment [ Time Frame: 3, 6 and 10 days ]
    Variation of the patient's score according to the Brescia COVID-19 Respiratory Severity Scale (minimum value 0, maximum value 8; higher scores mean a worse outcome) with baseline, assessed at 3, 6 and 10 days after treatment.

  2. Occurence of CTCAE 5.0 adverse events [ Time Frame: 10 days and 6 months ]
    Evaluation of the safety and tolerance of the low-dose radiotherapy treatment of SARS-Cov2 ( using the CTCAE 5.0 scale)

  3. Variation of the chest X-ray radiological findings according to Brixia scoring system [ Time Frame: 3 and 6 days ]
    Variation of the radiological findings, assessed by chest X-ray (performed 3 and 6 days after treatment) and defined according to the Brixia scoring system (0-18 scale, with 18 meaning the worse outcome)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT04377477


Contacts
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Contact: Stefano M Magrini, Prof ++393492970156 stefano.magrini@unibs.it
Contact: Davide Tomasini, MD ++393331404184 tomad88@libero.it

Locations
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Italy
Radiation Oncology Department, ASST SpedaliCivili, Brescia Recruiting
Brescia, Italy, 25123
Contact: Stefano M Magrini, Prof    039 0303995 ext 281    stefano.magrini@unibs.it   
Contact: Davide Tomasini, MD    039 0303995 ext 281    davide.tomasini@unibs.it   
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Investigators
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Principal Investigator: Stefano M Magrini, Prof Brescia University - ASST Spedali Civili Hospital
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Responsible Party: Stefano Maria Magrini, Prof, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT04377477    
Other Study ID Numbers: NP 4097
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Participant Data that underlie results in the publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefano Maria Magrini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:
RADIOTHERAPY
PNEUMONITIS
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections