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

Sponsor
Fundacion GenesisCare
Study ID
NCT04394182
Status
Suspended

Conditions

  • Cytokine Storm
  • Pneumonia, Viral

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultra-Low-dose radiotherapy — RADIATION
    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.
  • ventilatory support with oxygen therapy — DEVICE
    Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
  • Lopinavir/ritonavir — DRUG
    100/400 mg/12h; 7-10 days
  • Hydroxychloroquine — DRUG
    200 mg/12h
  • Azithromycin — DRUG
    500 mg/24h, 3 days
  • Piperacillin/tazobactam — DRUG
    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
  • Low molecular weight heparin — DRUG
    prophylactic doses
  • Corticosteroid injection — DRUG
    250mg x 3 boluses
  • Tocilizumab — DRUG
    600mg single dose

Study Details

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.

Key Dates

Start date
Apr 21, 2020
Status verified
Mar 2022
Primary completion
Dec 31, 2020
Completion
Mar 21, 2022

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: An experimental group receiving radiotherapy
    an experimental group with a poor or no response to standard medical treatment and without invasive mechanical ventilation (IMV) will receive ultra low-dose lung radiotherapy (0.8 Gy single dose)

Primary Outcome Measure

Oxygen Therapy Status at Day 2 [ Time Frame: At 2 after RT ]

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