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

San Carlos Clinical Hospital

Status: Unknown

Conditions: Covid19

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04420390

LOWRAD-Cov19

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Radiotherapy

Experimental group

Treatment:

Radiation: Radiotherapy