Low Dose Radiotherapy for COVID-19 Pneumonitis (LOWRAD-Cov19)
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Radiotherapy, Antiinflammatory, Pneumonitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Severe comorbidities that could hamper the radiation treatment.
Sites / Locations
- Servicio de Oncología Radioterápica. Hospital Clínico San CarlosRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Radiological response
Radiological results: Radiological worsening, improvement or without significant changes
Radiological response
Radiological results: Radiological worsening, improvement or without significant changes
Secondary Outcome Measures
Remission of respiratory symptoms
Remission of respiratory symptoms
SPO2 and PaO2/FiO2
Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen
Adverse events
Occurrence and grade of CTCAE 5.0 adverse events
Hospitalization
Duration of hospitalization
Overall survival
Overall survival
Ferritin value
ferritin value (ng/mL)
Ferritin value
ferritin value (ng/mL)
Ferritin value
ferritin value (ng/mL)
blood cell count
blood cell count (unit/L)
blood cell count
blood cell count (unit/L)
blood cell count
blood cell count (unit/L)
C-reactive protein
C-reactive protein (mg/dl)
C-reactive protein
C-reactive protein (mg/dl)
C-reactive protein
C-reactive protein (mg/dl)
D-dimer
D-dimer (ng/ml)
D-dimer
D-dimer (ng/ml)
D-dimer
D-dimer (ng/ml)
LDH levels
LDH levels (UI/L)
LDH levels
LDH levels (UI/L)
LDH levels
LDH levels (UI/L)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04420390
Brief Title
Low Dose Radiotherapy for COVID-19 Pneumonitis
Acronym
LOWRAD-Cov19
Official Title
Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
September 8, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Radiotherapy, Antiinflammatory, Pneumonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Low-dose radiotherapy
Primary Outcome Measure Information:
Title
Radiological response
Description
Radiological results: Radiological worsening, improvement or without significant changes
Time Frame
3 days after low dose radiation
Title
Radiological response
Description
Radiological results: Radiological worsening, improvement or without significant changes
Time Frame
7 days after low dose radiation
Secondary Outcome Measure Information:
Title
Remission of respiratory symptoms
Description
Remission of respiratory symptoms
Time Frame
up to 6 months
Title
SPO2 and PaO2/FiO2
Description
Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen
Time Frame
7 days
Title
Adverse events
Description
Occurrence and grade of CTCAE 5.0 adverse events
Time Frame
1 year
Title
Hospitalization
Description
Duration of hospitalization
Time Frame
3 months
Title
Overall survival
Description
Overall survival
Time Frame
1 month
Title
Ferritin value
Description
ferritin value (ng/mL)
Time Frame
1 day after low dose radiation
Title
Ferritin value
Description
ferritin value (ng/mL)
Time Frame
2 days after low dose radiation
Title
Ferritin value
Description
ferritin value (ng/mL)
Time Frame
3 days after low dose radiation
Title
blood cell count
Description
blood cell count (unit/L)
Time Frame
1 day after low dose radiation
Title
blood cell count
Description
blood cell count (unit/L)
Time Frame
2 days after low dose radiation
Title
blood cell count
Description
blood cell count (unit/L)
Time Frame
3 days after low dose radiation
Title
C-reactive protein
Description
C-reactive protein (mg/dl)
Time Frame
1 day after low dose radiation
Title
C-reactive protein
Description
C-reactive protein (mg/dl)
Time Frame
2 days after low dose radiation
Title
C-reactive protein
Description
C-reactive protein (mg/dl)
Time Frame
3 days after low dose radiation
Title
D-dimer
Description
D-dimer (ng/ml)
Time Frame
1 day after low dose radiation
Title
D-dimer
Description
D-dimer (ng/ml)
Time Frame
2 days after low dose radiation
Title
D-dimer
Description
D-dimer (ng/ml)
Time Frame
3 days after low dose radiation
Title
LDH levels
Description
LDH levels (UI/L)
Time Frame
1 day after low dose radiation
Title
LDH levels
Description
LDH levels (UI/L)
Time Frame
2 days after low dose radiation
Title
LDH levels
Description
LDH levels (UI/L)
Time Frame
3 days after low dose radiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
1. Severe comorbidities that could hamper the radiation treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Gonzalo Vazquez Masedo, MD,PhD
Phone
913003000
Email
manuelgonzalo.vazquez@salud.madrid.org
Facility Information:
Facility Name
Servicio de Oncología Radioterápica. Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Gonzalo Vazquez Masedo, MD, PhD
Phone
913003000
Email
manuelgonzalo.vazquez@salud.madrid.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low Dose Radiotherapy for COVID-19 Pneumonitis
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