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COVID-19: ultra-Low Radiotherapy Dose1: Colorado-1 trial

COVID-19: ultra-Low Radiotherapy Dose1: Colorado-1 trial - COLORADO-1

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49967
Enrollment
25
Registered
2020-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 pneumonia

Interventions

Ultra-low dose radiotherapy treatment of 0.5 Gy to both lungs.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The main endpoint will be supplemental oxygen use; 1, 3 and 5 days after treatment, and at discharge (or after 21 days).

Secondary

MeasureTime frame
Secondary endpoints will be survival, vital parameters, pro-inflammatory parameters in the blood, and lesion changes on imaging.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)