Low Dose Lung Radiotherapy to Treat COVID-19 Pneumonia

NCT04572412 | Completed DMC

• 1 other identifier: 285167
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to document the feasibility and tolerability of low dose thoracic radiotherapy in patients with WHO level 5 COVID 19 infections.

Conditions

Covid19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Feasibility of Recruitment

  Feasibility to recruit to the study.

  6 months

• Tolerability of Low dose Radiotherapy

  Proportion of patients with no decline in PaO2/FiO2 ratio (P/F Ratio) at 48 hours after each fraction of radiotherapy

  48 hours

Secondary Outcomes (3)

• Withdrawal

  6 months

• Adverse events

  1 month

• Feasibility of biochemical analysis

  1 week

Study Arms (1)

Low Dose Radiotherapy

EXPERIMENTAL

Low Dose Radiotherapy

Radiation: Low dose Radiotherapy

Interventions

Low dose Radiotherapy RADIATION

External Beam irradiation, single fraction of 0.5Gy, to be delivered within 48 hours of enrolment to study. With field to cover as close to lung edges as AP/PA technique allows. A further 0.5GY to the thorax given up to 96 hours apart from first fraction is permitted, if a patient had either (a) responded to the first dose but then deteriorated, however remaining better than baseline level or (b) stabilized after first dose but not fully improved.

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 have symptoms of COVID-19 infection as per WHO guidelines (e.g. cough, fever, dyspnea, etc.) for under 5 days from hospital admission.
• Patients are hospitalized and meet the criteria for WHO level 5 COVID pneumonia. In addition:
• SpO2 \<94% on Room Air;
• Respiratory rate \>20 Breaths per minute on Room Air.
• Laboratory confirmed COVID-19 infection based on PCR.
• Patients need ward-based oxygen between 28 to 40%.
• Patients able to provide witnessed verbal informed consent.
• Patient is free of other severe medical conditions that would preclude radiotherapy treatment (e.g. severe recent CVA).

You may not qualify if:

• Pregnant or lactating women.
• Presence of secondary infection with procalcitonin assessment at baseline.
• Patient is generating aerosols e.g. use of CPAP device.
• Hereditary syndromes known to have increase sensitivity to Radiotherapy including, but not limited to, ataxia-telangiectasia, and Njemgen Breakage Syndrome.
• History of prior thoracic radiotherapy.
• Inability to undergo radiotherapy for any reason as determined by the treating medical team.
• Alternative diagnosis for lung compromise unrelated to COVID-19 / deemed more likely than COVID-19 related lung compromise.
• Inability to consent directly.
• If patient has participated in any other COVID-19 therapy study within the last month (4 weeks).
• Pre-existing generalized pulmonary fibrosis.
• Known prior systemic use of the following drugs within the last 6 months: Bleomycin, Carmustine, Methotrexate, Busulfan, Cyclophosphamide, or Amiodarone.
• History of lung lobectomy or pneumonectomy.
• Known history of pulmonary sarcoidosis, Wegener's Granulomatosis, Systemic Lupus Erythematosus, or other autoimmune disease affecting lungs.
• Symptomatic congestive heart failure within the past 6 months including during hospitalization.
• History of recent or current malignancy receiving any cytotoxic chemotherapy or immunotherapy within the past 6 months.

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Lancashire Teaching Hospitals NHS

Preston, United Kingdom

Location

Related Publications (3)

• Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70.

  PMID: 24348219 BACKGROUND

• Lara PC, Burgos J, Macias D. Low dose lung radiotherapy for COVID-19 pneumonia. The rationale for a cost-effective anti-inflammatory treatment. Clin Transl Radiat Oncol. 2020 Apr 25;23:27-29. doi: 10.1016/j.ctro.2020.04.006. eCollection 2020 Jul.

  PMID: 32373721 BACKGROUND

• Hadjiyiannakis D, Dimitroyannis D, Eastlake L, Peedell C, Tripathi L, Simcock R, Vyas A, Deutsch E, Chalmers AJ. Personal View: Low-Dose Lung Radiotherapy Should be Evaluated as a Treatment for Severe COVID-19 Lung Disease. Clin Oncol (R Coll Radiol). 2021 Jan;33(1):e64-e68. doi: 10.1016/j.clon.2020.08.003. Epub 2020 Aug 14. No abstract available.

  PMID: 32829986 BACKGROUND

Related Links

• Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia: Planned Day-7 Interim Analysis of a Registered Clinical Trial

MeSH Terms

Conditions

COVID-19

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dennis Hadjiyiannakis

  LTHTR

  PRINCIPAL INVESTIGATOR

• Aashish Vyas

  LTHTR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 1, 2020
• Study Start: November 25, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)