Low Dose Radiotherapy for COVID-19 Pneumonitis
LOWRAD-Cov19
Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis
1 other identifier
interventional
41
1 country
1
Brief Summary
SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality. The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started May 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2020
CompletedJune 9, 2020
June 1, 2020
3 months
May 14, 2020
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiological response
Radiological results: Radiological worsening, improvement or without significant changes
3 days after low dose radiation
Radiological response
Radiological results: Radiological worsening, improvement or without significant changes
7 days after low dose radiation
Secondary Outcomes (20)
Remission of respiratory symptoms
up to 6 months
SPO2 and PaO2/FiO2
7 days
Adverse events
1 year
Hospitalization
3 months
Overall survival
1 month
- +15 more secondary outcomes
Study Arms (1)
Radiotherapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age ≥ 60 years.
- COVID19 + confirmed by PCR.
- Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement.
- Phase II or lung phase without any improvement with pharmacological treatment.
- Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment
- Poor clinical and functional respiratory evolution: \> 30 breaths / minute, SpO2 \<93%, PaO2 / FiO2 \<300.
- D-dimer\> 1000 ng / mL or rising, ferritin\> 1000 ng / mL, PCR\> 10 mg / dL or double than before.
You may not qualify if:
- \. Severe comorbidities that could hamper the radiation treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Oncología Radioterápica. Hospital Clínico San Carlos
Madrid, 28040, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 14, 2020
First Posted
June 9, 2020
Study Start
May 1, 2020
Primary Completion
July 31, 2020
Study Completion
September 8, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share