Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Study ID
NCT04380818
Status
Unknown

Conditions

  • Pneumonia, Viral

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose radiotherapy — RADIATION
    Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
  • Hydroxychloroquine Sulfate — DRUG
    200 mg/12h for 5 days
  • Ritonavir/lopinavir — DRUG
    400/100 mg/12h for 7-10 days
  • Tocilizumab Injection [Actemra] — DRUG
    600 mg/day for 1-2 doses
  • Azithromycin — DRUG
    500 mg/24h for 3 days
  • Corticosteroid — DRUG
    Corticosteroids (methylprednisolone/dexamethasone/prednisone)
  • Low molecular weight heparin — DRUG
    low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
  • Oxygen supply — DEVICE
    Oxygen

Study Details

Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.

Key Dates

Start date
Jun 5, 2020
Status verified
Jul 2021
Primary completion
Sep 4, 2021
Completion
Nov 1, 2021

Study Design

Enrollment
106 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control group
    a control group only receive pharmacological treatment
  • Experimental: Experimental group
    an experimental group will receive low-dose lung irradiation

Primary Outcome Measure

Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20% [ Time Frame: Day 2 after interventional radiotherapy ]

Central Contacts

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