COVIDPhase 1/2NCT04390412
Low Dose Radiotherapy in COVID-19 Pneumonia
A Phase 1/2 study testing Low Dose Radiotherapy in people with COVID and SARS (Severe Acute Respiratory Syndrome), run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID, SARS (Severe Acute Respiratory Syndrome)
- 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
- 5 participants
- Where
- 1 siteIran
- Study dates
- 4 May 2020to Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
- Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
- Less than 3 days since the onset of ARDS
- Age > 60 years
- ↑ IL-6 ( if available)
- ↑ CRP
Who cannot join
- Lack of informed consent
- Inability to transfer to the radiation unit
- Hemodynamic instability
- Septic shock and organ dysfunction
- Severe ARDS P/F ratio ≤ 100 mmHg
- History of cardiac failure
- Contraindications to radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.
Read the detailed description
SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.
Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.
In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.
A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.
- Conditions
- COVID, SARS (Severe Acute Respiratory Syndrome)
- Being tested
- Low Dose Radiotherapy
- Keywords
- Low Dose Lung Radiotherapy, COVID-19, anti-inflammatory
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose RadiotherapyRadiation
0.5 Gy radiation to both lungs in an AP/PA treatment plan
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Radiotherapy | Experimental | 0.5 Gy radiation to both lungs in an AP/PA fashion Receives: Radiation: Low Dose Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline blood oxygenation
O2 saturation
Measured: 28 days
Number of Hospital stay days
Total days the patient is admitted to hospital
Measured: 28 days
Number of ICU stay days
Total days the patient is admitted to ICU
Measured: 28 days
Number of intubation events
Total number of intubations performed after the treatment
Measured: 28 days
Secondary outcomes (12)
WBC
Changes in WBC count if base-line is abnormal
Measured: 28 days
Platelets
Changes in Platelets count if base-line is abnormal
Measured: 28 days
CRP
Changes in CRP serum level
Measured: Day 1
CRP
Changes in CRP serum level
Measured: Day 2
CRP
Changes in CRP serum level
Measured: Day 3
CRP
Changes in CRP serum level
Measured: Day 4
CRP
Changes in CRP serum level
Measured: Day 5
IL-6
Changes in IL-6 serum level
Measured: Day 1
IL-6
Changes in IL-6 serum level
Measured: Day 2
IL-6
Changes in IL-6 serum level
Measured: Day 3
IL-6
Changes in IL-6 serum level
Measured: Day 4
IL-6
Changes in IL-6 serum level
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start4 May 2020
- Primary completion30 Aug 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad Ameri, Prof., Study chair, Shahid Beheshti University of Medical SciencesNazanin Rahnama, M.D., Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390412
- Sponsor's protocol ID
- 23568
- Other IDs
- IRCT20200509047366N1
- Status last verified
- Jul 2020
- First submitted
- 13 May 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after the completion of study to other researchers.
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 24348219Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rodel C, Weiss C, Rodel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8.
PubMed 26051282Clayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020
Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. No abstract available.
PubMed 32342871Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. No abstract available.
PubMed 32342874Stefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04390412
- Acronym / sponsor ID
- 23568
- Conditions
- COVID, SARS (Severe Acute Respiratory Syndrome)
- Keywords
- Low Dose Lung Radiotherapy, COVID-19, anti-inflammatory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 May 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.
Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.
Detailed description
SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.
Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.
In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.
A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.
Study design
- Primary purpose
- Supportive care
- 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 Radiotherapy0.5 Gy radiation to both lungs in an AP/PA fashion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
- Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
- Less than 3 days since the onset of ARDS
- Age > 60 years
- ↑ IL-6 ( if available)
Key exclusion criteria (7 listed)
- Lack of informed consent
- Inability to transfer to the radiation unit
- Hemodynamic instability
- Septic shock and organ dysfunction
- Severe ARDS P/F ratio ≤ 100 mmHg
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 Radiotherapy0.5 Gy radiation to both lungs in an AP/PA treatment plan | Radiation | Low Dose Radiotherapy |
Primary outcome
Change from baseline blood oxygenation
Time frame: 28 days
O2 saturation
Number of Hospital stay days
Time frame: 28 days
Total days the patient is admitted to hospital
Number of ICU stay days
Time frame: 28 days
Total days the patient is admitted to ICU
Number of intubation events
Time frame: 28 days
Total number of intubations performed after the treatment
12 secondary outcomes
WBC
Time frame: 28 days
Platelets
Time frame: 28 days
CRP
Time frame: Day 1
CRP
Time frame: Day 2
CRP
Time frame: Day 3
CRP
Time frame: Day 4
CRP
Time frame: Day 5
IL-6
Time frame: Day 1
IL-6
Time frame: Day 2
IL-6
Time frame: Day 3
IL-6
Time frame: Day 4
IL-6
Time frame: Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- 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 26051282Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rodel C, Weiss C, Rodel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8.
- BackgroundClayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020
- Background: PubMed 32342871Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. No abstract available.
- Background: PubMed 32342874Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. No abstract available.
- BackgroundStefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477
- Individual participant dataSharing planned: Yes. IPD will be shared after the completion of study to other researchers.
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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.
Ahmad Ameri, Prof. study chair
Shahid Beheshti University of Medical Sciences
Nazanin Rahnama, M.D. principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Dose Radiotherapy in people with COVID and SARS (Severe Acute Respiratory Syndrome), run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 6 inclusion and 7 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 10 Nov 2020. 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 Iran. 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.
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?
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?
Change from baseline blood oxygenation (time frame: 28 days). The study lists 4 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 NCT04390412, which also lists 6 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 2020.