Low Dose Radiotherapy for COVID-19 Pneumonitis

N/AUnknownNCT04420390

Hospital San Carlos, Madrid41 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Radiological response

Radiological results: Radiological worsening, improvement or without significant changes

Time frame: 3 days after low dose radiation

Radiological response

Radiological results: Radiological worsening, improvement or without significant changes

Time frame: 7 days after low dose radiation

Secondary Outcomes

Remission of respiratory symptoms

Time frame: up to 6 months

SPO2 and PaO2/FiO2

Time to SPO2\>94% or PaO2/FiO2 \>350mmHg without oxygen

Time frame: 7 days

Adverse events

Occurrence and grade of CTCAE 5.0 adverse events

Time frame: 1 year

Hospitalization

Duration of hospitalization

Time frame: 3 months

Overall survival

Time frame: 1 month

Ferritin value

ferritin value (ng/mL)

Time frame: 1 day after low dose radiation

Ferritin value

ferritin value (ng/mL)

Time frame: 2 days after low dose radiation

Ferritin value

ferritin value (ng/mL)

Time frame: 3 days after low dose radiation

blood cell count

blood cell count (unit/L)

Time frame: 1 day after low dose radiation

blood cell count

blood cell count (unit/L)

Time frame: 2 days after low dose radiation

blood cell count

blood cell count (unit/L)

Time frame: 3 days after low dose radiation

C-reactive protein

C-reactive protein (mg/dl)

Time frame: 1 day after low dose radiation

C-reactive protein

C-reactive protein (mg/dl)

Time frame: 2 days after low dose radiation

C-reactive protein

C-reactive protein (mg/dl)

Time frame: 3 days after low dose radiation

D-dimer

D-dimer (ng/ml)

Time frame: 1 day after low dose radiation

D-dimer

D-dimer (ng/ml)

Time frame: 2 days after low dose radiation

D-dimer

D-dimer (ng/ml)

Time frame: 3 days after low dose radiation

LDH levels

LDH levels (UI/L)

Time frame: 1 day after low dose radiation

LDH levels

LDH levels (UI/L)

Time frame: 2 days after low dose radiation

LDH levels

LDH levels (UI/L)

Time frame: 3 days after low dose radiation

Low Dose Radiotherapy for COVID-19 Pneumonitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts