To determine the pre-liminary efficacy of ultra-low dose radiotherapy for COVID-19 related pneumonia with respiratory insufficiency.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint will be supplemental oxygen use; 1, 3 and 5 days after
treatment, and at discharge (or after 21 days).
Secondary outcome
Secondary endpoints will be survival, vital parameters, pro-inflammatory
parameters in the blood, and lesion changes on imaging.
Background summary
Ultra-low dose thoracic radiotherapy was used to treat bacterial and viral
pneumonias in the first half of the 20th century, with clinical improvement
within 24-48 hours, as reported in over 700 patients. Modern preclinical and
clinical data suggest doses of 0.3-1 Gy induce an anti-inflammatory effect. Our
hypothesis is that a single fraction of 0.5 Gy (approximately 1% of many cancer
treatments) may decrease the host immune response within the lung to decrease
lung injury.
Study objective
To determine the pre-liminary efficacy of ultra-low dose radiotherapy for
COVID-19 related pneumonia with respiratory insufficiency.
Study design
Single-arm, phase II trial for 25 patients.
Intervention
Ultra-low dose radiotherapy treatment of 0.5 Gy to both lungs.
Study burden and risks
For the patients included in the study, the potential benefit of an alleviating
therapy is associated with the treatment performed. Regarding the patients*
burden, a transfer to and from the ward to the department of radiation oncology
and treatment room. The radiation planning and treatment will take
approximately 10 minutes, during which supplemental oxygen will be available
(beam on time 1-2 minutes). Due to the ultra-low dose, we expect no side
effects from the treatment itself. Furthermore, we will perform a chest X-ray
twice, at baseline and at discharge or 21 days after treatment, which will take
approximately 5 minutes per X-ray. At baseline, 1, 3 and 5 days after treatment
and at discharge or 21 days after treatment, blood will be collected. If
possible, this will be combined with blood tests in standard care. All clinical
and technical data, including patient characteristics, clinical parameters,
blood test results and data form imaging, acquired in standard care, can be
used for the study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* PCR confirmed positive for SARS-CoV-2
* Progressive respiratory insufficiency with the following:
o National Early Warning Score (NEWS) * 5.
o Respiratory rate * 20/min
o Supplemental oxygen * 6L/min
* DNR (Do not resuscitate, *NRNB*).
* Clinical frailty scale 5-8 at admission.
* Age * 50 years.
* Ability of subject to understand character and individual consequences of the
clinical trial.
Exclusion criteria
* Medical indication to be treated at the ICU (intensive care unit).
* Current participation in other intervention studies.
* Prior thoracic radiotherapy only if * grade 3 toxicity has been registered.
* Inability to undergo radiotherapy or transportation, for any reason as
determined by the treating physician.
* Alternative diagnosis for respirator insufficiency which is considered to be
more likely than COVID-19.
* Current treatment with immunomodulating therapy other than steroids.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73841.041.20 |