Clinical trial NCT04420390: Low Dose Radiotherapy for COVID-19 Pneumonitis
Official title: Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: Radiotherapy
Antiinflammatory
Pneumonitis
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 41
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Radiological response
timeFrame: 3 days after low dose radiation
measure: Radiological response
timeFrame: 7 days after low dose radiation
Secondary outcomes:
measure: Remission of respiratory symptoms
timeFrame: up to 6 months
measure: SPO2 and PaO2/FiO2
timeFrame: 7 days
measure: Adverse events
timeFrame: 1 year
measure: Hospitalization
timeFrame: 3 months
measure: Overall survival
timeFrame: 1 month
measure: Ferritin value
timeFrame: 1 day after low dose radiation
measure: Ferritin value
timeFrame: 2 days after low dose radiation
measure: Ferritin value
timeFrame: 3 days after low dose radiation
measure: blood cell count
timeFrame: 1 day after low dose radiation
measure: blood cell count
timeFrame: 2 days after low dose radiation
measure: blood cell count
timeFrame: 3 days after low dose radiation
measure: C-reactive protein
timeFrame: 1 day after low dose radiation
measure: C-reactive protein
timeFrame: 2 days after low dose radiation
measure: C-reactive protein
timeFrame: 3 days after low dose radiation
measure: D-dimer
timeFrame: 1 day after low dose radiation
measure: D-dimer
timeFrame: 2 days after low dose radiation
measure: D-dimer
timeFrame: 3 days after low dose radiation
measure: LDH levels
timeFrame: 1 day after low dose radiation
measure: LDH levels
timeFrame: 2 days after low dose radiation
measure: LDH levels
timeFrame: 3 days after low dose radiation
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Oncología Radioterápica. Hospital Clínico San Carlos
Study officials:
References: