Low Dose Radiotherapy for COVID-19 Pneumonitis

Covid19 Clinical Trial

— LOWRAD-Cov19  

Official title:

Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04420390
• Other study ID #: LOWRAD-Cov19
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 8, 2020

Study information

• Verified date: June 2020
• Source: Hospital San Carlos, Madrid
• Contact: Manuel Gonzalo Vazquez Masedo, MD,PhD
• Phone: 913003000
• Email: manuelgonzalo.vazquez[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: September 8, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age = 60 years.

2. COVID19 + confirmed by PCR.

3. Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement.

4. Phase II or lung phase without any improvement with pharmacological treatment.

5. Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment

6. Poor clinical and functional respiratory evolution: > 30 breaths / minute, SpO2 <93%, PaO2 / FiO2 <300.

7. 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.

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

Radiation:
• Radiotherapy
Low-dose radiotherapy

Locations

Country	Name	City	State
Spain	Servicio de Oncología Radioterápica. Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological response	Radiological results: Radiological worsening, improvement or without significant changes	3 days after low dose radiation
Primary	Radiological response	Radiological results: Radiological worsening, improvement or without significant changes	7 days after low dose radiation
Secondary	Remission of respiratory symptoms	Remission of respiratory symptoms	up to 6 months
Secondary	SPO2 and PaO2/FiO2	Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen	7 days
Secondary	Adverse events	Occurrence and grade of CTCAE 5.0 adverse events	1 year
Secondary	Hospitalization	Duration of hospitalization	3 months
Secondary	Overall survival	Overall survival	1 month
Secondary	Ferritin value	ferritin value (ng/mL)	1 day after low dose radiation
Secondary	Ferritin value	ferritin value (ng/mL)	2 days after low dose radiation
Secondary	Ferritin value	ferritin value (ng/mL)	3 days after low dose radiation
Secondary	blood cell count	blood cell count (unit/L)	1 day after low dose radiation
Secondary	blood cell count	blood cell count (unit/L)	2 days after low dose radiation
Secondary	blood cell count	blood cell count (unit/L)	3 days after low dose radiation
Secondary	C-reactive protein	C-reactive protein (mg/dl)	1 day after low dose radiation
Secondary	C-reactive protein	C-reactive protein (mg/dl)	2 days after low dose radiation
Secondary	C-reactive protein	C-reactive protein (mg/dl)	3 days after low dose radiation
Secondary	D-dimer	D-dimer (ng/ml)	1 day after low dose radiation
Secondary	D-dimer	D-dimer (ng/ml)	2 days after low dose radiation
Secondary	D-dimer	D-dimer (ng/ml)	3 days after low dose radiation
Secondary	LDH levels	LDH levels (UI/L)	1 day after low dose radiation
Secondary	LDH levels	LDH levels (UI/L)	2 days after low dose radiation
Secondary	LDH levels	LDH levels (UI/L)	3 days after low dose radiation