Status:
UNKNOWN
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
Lead Sponsor:
Grupo de Investigación Clínica en Oncología Radioterapia
Collaborating Sponsors:
Hospital Universitario Madrid Sanchinarro
Hospital del Mar
Conditions:
Pneumonia, Viral
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it...
Detailed Description
Study design: This is a prospective multicenter study in 2 phases: 1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum...
Eligibility Criteria
Inclusion
- Age \>=18 years old
- Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses
- PAFIO2 of less than 300 mmHg or SaFI02 \<315 mmHg
- Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.
- One of the following conditions:
- or IL6 greater than 40
- or PCR\> 100mg / l
- D-dimer greater than 1500ng / ml
- Suspected cytokine release syndrome
- Have read the information sheet and signed the informed consent
Exclusion
- Age \<18 years
- Failure to meet the inclusion criteria
- Leukopenia \<1000
- Pregnancy
- Not understanding or refusing the purpose of the study
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04380818
Start Date
June 5 2020
End Date
November 1 2021
Last Update
July 30 2021
Active Locations (3)
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1
Hospital Sant Joan de Reus
Reus, Tarragona, Spain, 43204
2
Hospital Del Mar
Barcelona, Spain, 08003
3
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050