Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Summary

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients.

In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose \< 1 Gy.

The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

Conditions

• Pneumonia, Viral
• Cytokine Storm

Interventions

RADIATION

Ultra-Low-dose radiotherapy

The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.

DEVICE

ventilatory support with oxygen therapy

Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir

DRUG

Lopinavir/ritonavir

100/400 mg/12h; 7-10 days

DRUG

Hydroxychloroquine

200 mg/12h

DRUG

Azithromycin

500 mg/24h, 3 days

DRUG

Piperacillin/tazobactam

4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function

DRUG

Low molecular weight heparin

prophylactic doses

DRUG

Corticosteroid injection

250mg x 3 boluses

DRUG

Tocilizumab

600mg single dose

Sponsors & Collaborators

• Hospital La Milagrosa

  collaborator UNKNOWN

• Hospital Vithas Valencia Consuelo

  collaborator UNKNOWN

• Fundacion GenesisCare

  lead NETWORK

Principal Investigators

• Escarlata López Ramírez, MD, PhD · Fundacion GenesisCare

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-21

Primary Completion

2020-12-31

Completion

2022-03-21

Countries

• Spain

Study Locations