Trial | NCT04380818  Report issue

Title

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    106
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.
Study design: This is a prospective multicenter study in 2 phases:

Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued.
Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.
Study Started
Jun 05
2020
Primary Completion
Sep 04
2021
Anticipated
Study Completion
Nov 01
2021
Anticipated
Last Update
Jul 30
2021

Radiation Low-dose radiotherapy

Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later

Drug Hydroxychloroquine Sulfate

200 mg/12h for 5 days

  • Other names: Dolquine

Drug Ritonavir/lopinavir [ritonavir (Norvir), lopinavir (Kaletra)]

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

  • Other names: Kaletra

Drug Tocilizumab Injection [Actemra]

600 mg/day for 1-2 doses

  • Other names: Actemra

Drug Azithromycin

500 mg/24h for 3 days

Drug Corticosteroid

Corticosteroids (methylprednisolone/dexamethasone/prednisone)

Drug Low molecular weight heparin

low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism

Device Oxygen supply

Oxygen

Control group Active Comparator

a control group only receive pharmacological treatment

Experimental group Experimental

an experimental group will receive low-dose lung irradiation

Criteria 

Inclusion Criteria:

Age >=18 years old
Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses
PAFIO2 of less than 300 mmHg or SaFI02 <315 mmHg
Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.

One of the following conditions:

or IL6 greater than 40

or PCR> 100mg / l

D-dimer greater than 1500ng / ml
Suspected cytokine release syndrome
Have read the information sheet and signed the informed consent

Exclusion Criteria:

Age <18 years
Failure to meet the inclusion criteria
Leukopenia <1000
Pregnancy
Not understanding or refusing the purpose of the study
No Results Posted