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

Grupo de Investigación Clínica en Oncología Radioterapia

Status: Unknown

Conditions: Pneumonia, Viral

Treatments: Device: Oxygen supply; Drug: Low molecular weight heparin; Drug: Azithromycin; Drug: Tocilizumab Injection [Actemra]; Radiation: Low-dose radiotherapy; Drug: Hydroxychloroquine Sulfate; Drug: Corticosteroid; Drug: Ritonavir/lopinavir

Study type: Interventional

Funder types: Other

Identifiers

NCT04380818

IPACOVID

Details and patient eligibility

About

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.

Full description

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

1. 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.
2. 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control group

Active Comparator group

Description:

a control group only receive pharmacological treatment

Treatment:

Device: Oxygen supply

Drug: Ritonavir/lopinavir

Drug: Low molecular weight heparin

Drug: Hydroxychloroquine Sulfate

Drug: Azithromycin

Drug: Tocilizumab Injection [Actemra]

Drug: Corticosteroid

Experimental group

Experimental group

Description:

an experimental group will receive low-dose lung irradiation

Treatment:

Radiation: Low-dose radiotherapy

Device: Oxygen supply

Drug: Ritonavir/lopinavir

Drug: Low molecular weight heparin

Drug: Hydroxychloroquine Sulfate

Drug: Azithromycin

Drug: Tocilizumab Injection [Actemra]

Drug: Corticosteroid