Low Dose Radiotherapy for COVID-19 Pneumonitis

Not Applicable

• Conditions: Covid19
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT04420390
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-14
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Radiological response	7 days after low dose radiation	Radiological results: Radiological worsening, improvement or without significant changes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Servicio de Oncología Radioterápica. Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain