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

First listed
May 8, 2020
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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