Low Dose Radiotherapy for COVID-19 Pneumonitis (LOWRAD-Cov19)

Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Gonzalo Vazquez Masedo, MD,PhD; Phone Number: 913003000; Email: manuelgonzalo.vazquez@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Servicio de Oncología Radioterápica. Hospital Clínico San Carlos
    • Contact: Manuel Gonzalo Vazquez Masedo, MD, PhD; Phone Number: 913003000; Email: manuelgonzalo.vazquez@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy	Radiation: Radiotherapy; Low-dose radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): September 8, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Radiotherapy; Pneumonitis; Antiinflammatory
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: LOWRAD-Cov19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No