Covid19NCT04572412
Low Dose Lung Radiotherapy to Treat COVID-19 Pneumonia
A study testing Low dose Radiotherapy in people with Covid19, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Low dose Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- Bone marrow transplantation.
- Latent tuberculosis.
- Any solid organ transplant (renal, cardiac, liver, lung) requiring immunosuppressive therapy.
- Septic shock and organ dysfunction.
- Severe ARDS P/F ratio ≤100mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Lung Radiotherapy to Treat COVID-19 Pneumonia (a Phase I Feasibility Trial)
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.
Read the detailed description
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.
- Conditions
- Covid19
- Being tested
- Low dose Radiotherapy
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Radiotherapy | Experimental | Low Dose Radiotherapy Receives: Radiation: Low dose Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
Feasibility to recruit to the study.
Measured: 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
Measured: 48 hours
Secondary outcomes (3)
Withdrawal
The number of patients who withdraw from the study
Measured: 6 months
Adverse events
The number of Grade 4 or higher CTCAE v5 (apart from asymptomatic lymphopenia) adverse events reported
Measured: 1 month
Feasibility of biochemical analysis
Ability to perform lymphocyte subset, IL-6, and IL-10 analysis at baseline and 7 days post last fraction of radiotherapy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start25 Nov 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Dennis Hadjiyiannakis, Principal investigator, LTHTRAashish Vyas, Principal investigator, LTHTR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572412
- Sponsor's protocol ID
- 285167
- Status last verified
- Nov 2022
- First submitted
- 29 Sep 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be kept anonymized and confidential. Data will be held securely for 15 years pending further study.
Publications
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.
PubMed 24348219Lara 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.
PubMed 32373721Hadjiyiannakis 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.
PubMed 32829986
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Lung Radiotherapy to Treat COVID-19 Pneumonia (a Phase I Feasibility Trial)
- ClinicalTrials.gov ID
- NCT04572412
- Acronym / sponsor ID
- 285167
- Conditions
- Covid19
- Keywords
- SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Dose Radiotherapy | Experimental | Radiation: Low dose RadiotherapyLow Dose Radiotherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose RadiotherapyExternal 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. | Radiation | Low Dose Radiotherapy |
Primary outcome
Feasibility of Recruitment
Time frame: 6 months
Feasibility to recruit to the study.
Tolerability of Low dose Radiotherapy
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
3 secondary outcomes
Withdrawal
Time frame: 6 months
Adverse events
Time frame: 1 month
Feasibility of biochemical analysis
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 24348219Calabrese 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.
- Background: PubMed 32373721Lara 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.
- Background: PubMed 32829986Hadjiyiannakis 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.
- Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia: Planned Day-7 Interim Analysis of a Registered Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. All data will be kept anonymized and confidential. Data will be held securely for 15 years pending further study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Hadjiyiannakis principal investigator
LTHTR
Aashish Vyas principal investigator
LTHTR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose Radiotherapy in people with Covid19, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.