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

July 29, 2021 updated by: Grupo de Investigación Clínica en Oncología Radioterapia

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario Madrid Sanchinarro
        • Contact:
    • Tarragona
      • Reus, Tarragona, Spain, 43204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
a control group only receive pharmacological treatment
Drug: Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Other Names:
  • Dolquine
Drug: Ritonavir/lopinavir
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
Experimental: Experimental group
an experimental group will receive low-dose lung irradiation
Drug: Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Other Names:
  • Dolquine
Drug: Ritonavir/lopinavir
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
Radiation: Low-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later

What is the study measuring?

Primary Outcome Measures

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

To evaluate the efficacy of low-dose pulmonary 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 baseline pre-irradiation measurement. .

In cases of impossibility the SaFiO2 will be determined
Day 2 after interventional radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Day 30 and day 90 after interventional radiotherapy
Lung toxicity measured according to CTCAEv5
Day 30 and day 90 after interventional radiotherapy
Change of the radiological image
Time Frame: Days 7 and day 30 after interventional radiotherapy
Chest CT
Days 7 and day 30 after interventional radiotherapy
Overall mortality
Time Frame: Day 15 and Day 30 after interventional radiotherapy
Death of any cause
Day 15 and Day 30 after interventional radiotherapy
Measure of pro-inflammatory interleukins
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)
Days 1, day 4 and day 7 after interventional radiotherapy
Measure of trasforming growth factor (TGF-b)
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
TGF-β (ng/ml)
Days 1, day 4 and day 7 after interventional radiotherapy
Measure of tumor necrosis factor alpha (TNF-a)
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
TNF-α (pg/ml)
Days 1, day 4 and day 7 after interventional radiotherapy
Determining overexpression of pro-inflammatory selectin
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
Overexpression of L-, E-, and P-selectin
Days 1, day 4 and day 7 after interventional radiotherapy
Determining cell adhesion molecules (CAMs)
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
Overexpression of ICAM-1, VCAM
Days 1, day 4 and day 7 after interventional radiotherapy
Measure of marker of oxidative stress PON-1
Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy
PON-1(paraoxonase and arylesterase activity) (IU/ml)
Days 1, day 4 and day 7 after interventional radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Collaborators

Hospital del Mar
Hospital Universitari Sant Joan de Reus
Hospital Universitario Madrid Sanchinarro

Investigators

  • Principal Investigator: Angel Montero, MD, PhD, Hospital Universitario Madrid Sanchinarro
  • Principal Investigator: Manel Algara, MD, PhD, Hospital Del Mar
  • Principal Investigator: Merirxell Arenas, MD, PhD, Hospital Universitario Sant Joan de Reus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Anticipated)

September 4, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPACOVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual epidemiological and clinical data will be shared after recruitment is complete.

IPD Sharing Time Frame

Protocol/ICF from approval Individual epidemiological and clinical data after recruitment is complete.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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