COVID-19: ultra-Low Radiotherapy Dose1: Colorado-1 trial
- Conditions
- COVID-19pneumonia1004743810024970
- Registration Number
- NL-OMON49967
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
* 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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint will be supplemental oxygen use; 1, 3 and 5 days after<br /><br>treatment, and at discharge (or after 21 days). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be survival, vital parameters, pro-inflammatory<br /><br>parameters in the blood, and lesion changes on imaging.</p><br>