COVID-19 PneumonitisPhase 1/2NCT04493294
Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
A Phase 1/2 study testing Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis in people with COVID-19 Pneumonitis, run by International Geriatric Radiotherapy Group.
Trial summary
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID-19 Pneumonitis
- What is being tested?
- Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2021
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen
Who cannot join
- Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis
Read the detailed description
Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.
Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.
Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.
Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.
- Conditions
- COVID-19 Pneumonitis
- Being tested
- Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
- Keywords
- COVID-19, pneumonitis, whole lung radiotherapy, low dose
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitisRadiation
Low dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
Measured: One year
Secondary outcomes (5)
Mortality rate
Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
Measured: One year
Duration of hospitalization
Duration of hospitalization for the whole group and different groups with or without oxygen requirement
Measured: One year
Time to recovery
Ordinal scale at the time of radiotherapy and 28 days later
Measured: One month
Oxygen saturation rate
Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
Measured: One year
Patient inflammatory status
Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumonitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Geriatric Radiotherapy Group
- Sponsor type
- University, hospital or other
- Collaborators
- Brigitta G. Baumert
- Responsible party
- Principal investigator, Nam Nguyen, International Geriatric Radiotherapy Group
- Investigators
- Brigitta G Baumert, M.D.Ph.D, Principal investigator, Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493294
- Sponsor's protocol ID
- IGRG01
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are over 40 people involved in the study, we need their approval before data sharing
Publications
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.
PubMed 32373721Lara PC, Nguyen NP, Macias-Verde D, Burgos-Burgos J, Arenas M, Zamagni A, Vinh-Hung V, Baumert BG, Motta M, Myint AS, Bonet M, Popescu T, Vuong T, Appalanaido GK, Trigo L, Karlsson U, Thariat J. Whole-lung Low Dose Irradiation for SARS-Cov2 Induced Pneumonia in the Geriatric Population: An Old Effective Treatment for a New Disease? Recommendation of the International Geriatric Radiotherapy Group. Aging Dis. 2020 May 9;11(3):489-493. doi: 10.14336/AD.2020.0506. eCollection 2020 May.
PubMed 32489696
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group
- ClinicalTrials.gov ID
- NCT04493294
- Acronym / sponsor ID
- IGRG01
- Conditions
- COVID-19 Pneumonitis
- Keywords
- COVID-19, pneumonitis, whole lung radiotherapy, low dose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Geriatric Radiotherapy GroupUniversity, hospital or other
- Collaborators
- Brigitta G. Baumert
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jul 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.
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis
Detailed description
Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.
Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.
Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.
Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen
Key exclusion criteria (1 listed)
- Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
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 whole lung radiotherapy for older patients with COVID-19 pneumonitisLow dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation | Radiation | – |
Primary outcome
Mortality rate
Time frame: One year
Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
5 secondary outcomes
Mortality rate
Time frame: One year
Duration of hospitalization
Time frame: One year
Time to recovery
Time frame: One month
Oxygen saturation rate
Time frame: One year
Patient inflammatory status
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- 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 32489696Lara PC, Nguyen NP, Macias-Verde D, Burgos-Burgos J, Arenas M, Zamagni A, Vinh-Hung V, Baumert BG, Motta M, Myint AS, Bonet M, Popescu T, Vuong T, Appalanaido GK, Trigo L, Karlsson U, Thariat J. Whole-lung Low Dose Irradiation for SARS-Cov2 Induced Pneumonia in the Geriatric Population: An Old Effective Treatment for a New Disease? Recommendation of the International Geriatric Radiotherapy Group. Aging Dis. 2020 May 9;11(3):489-493. doi: 10.14336/AD.2020.0506. eCollection 2020 May.
- Individual participant dataSharing planned: Undecided. There are over 40 people involved in the study, we need their approval before data sharing
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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.
Brigitta G Baumert, M.D.Ph.D principal investigator
Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis in people with COVID-19 Pneumonitis, run by International Geriatric Radiotherapy Group.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nam p Nguyen, MD (202-865-1421, namphong.nguyen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: One year). 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 NCT04493294, which also lists 2 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 30 Jul 2020.