Lancashire Teaching Hospitals NHS
Preston, United Kingdom
NCT Number: NCT04572412
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Preston, United Kingdom
Subjects will be identified following admission to hospital who test positive for COVID-19 infection. They will then be informed and consented, and eligibility confirmed and registered to study. Following this the first, sentinel patient, will be treated with 0.5Gy dose radiotherapy to cover the lungs, with heterogeneity correction. A further 0.5Gy dose can be repeated within 96 hours. There shall then be a 7 day gap prior to recruiting patient 2. The remaining patients will be recruited, treated and observed in cohorts of 3.
The patients shall then be followed up at 48 hours post Radiotherapy, 7 days post radiotherapy and 29 days post radiotherapy. With assessment of Physiological parameters, survival status, laboratory testing and imaging performed on follow up at 7 and 29 days.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Feasibility to recruit to the study.
Time frame: 48 hours
Proportion of patients with no decline in PaO2/FiO2 ratio (P/F Ratio) at 48 hours after each fraction of radiotherapy
Time frame: 6 months
The number of patients who withdraw from the study
Time frame: 1 month
The number of Grade 4 or higher CTCAE v5 (apart from asymptomatic lymphopenia) adverse events reported
Time frame: 1 week
Ability to perform lymphocyte subset, IL-6, and IL-10 analysis at baseline and 7 days post last fraction of radiotherapy
Lancashire Teaching Hospitals NHS Foundation Trust
Other
Low Dose Lung Radiotherapy to Treat COVID-19 Pneumonia (a Phase I Feasibility Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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