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

NCT04380818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Pneumonia, Viral

Interventions

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

DRUG

Ritonavir/lopinavir

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

DRUG

Tocilizumab Injection [Actemra]

600 mg/day for 1-2 doses

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

Sponsors & Collaborators

  • Hospital Universitario Madrid Sanchinarro

    collaborator OTHER

  • Hospital del Mar

    collaborator OTHER

  • Hospital Universitari Sant Joan de Reus

    collaborator OTHER

  • Grupo de Investigación Clínica en Oncología Radioterapia

    lead OTHER

Principal Investigators

  • Angel Montero, MD, PhD · Hospital Universitario Madrid Sanchinarro

  • Manel Algara, MD, PhD · Hospital del Mar

  • Merirxell Arenas, MD, PhD · Hospital Universitario Sant Joan de Reus

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2021-09-04
Completion
2021-11-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380818 on ClinicalTrials.gov