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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380818
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
Hospital Universitario Madrid Sanchinarro
Hospital del Mar
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Grupo de Investigación Clínica en Oncología Radioterapia

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE June 5, 2020
Estimated Primary Completion Date May 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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
  • Change of the radiological image [ Time Frame: Days 7 and day 30 after interventional radiotherapy ]
    Chest CT
  • Overall mortality [ Time Frame: Day 15 and Day 30 after interventional radiotherapy ]
    Death of any cause
  • 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)
  • Measure of trasforming growth factor (TGF-b) [ Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy ]
    TGF-β (ng/ml)
  • Measure of tumor necrosis factor alpha (TNF-a) [ Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy ]
    TNF-α (pg/ml)
  • 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
  • Determining cell adhesion molecules (CAMs) [ Time Frame: Days 1, day 4 and day 7 after interventional radiotherapy ]
    Overexpression of ICAM-1, VCAM
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
Official Title  ICMJE Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pneumonia, Viral
Intervention  ICMJE
  • 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 Name: Dolquine
  • Drug: Ritonavir/lopinavir
    400/100 mg/12h for 7-10 days
    Other Name: Kaletra
  • Drug: Tocilizumab Injection [Actemra]
    600 mg/day for 1-2 doses
    Other Name: 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
Study Arms  ICMJE
  • Active Comparator: Control group
    a control group only receive pharmacological treatment
    Interventions:
    • Drug: Hydroxychloroquine Sulfate
    • Drug: Ritonavir/lopinavir
    • Drug: Tocilizumab Injection [Actemra]
    • Drug: Azithromycin
    • Drug: Corticosteroid
    • Drug: Low molecular weight heparin
    • Device: Oxygen supply
  • Experimental: Experimental group
    an experimental group will receive low-dose lung irradiation
    Interventions:
    • Radiation: Low-dose radiotherapy
    • Drug: Hydroxychloroquine Sulfate
    • Drug: Ritonavir/lopinavir
    • Drug: Tocilizumab Injection [Actemra]
    • Drug: Azithromycin
    • Drug: Corticosteroid
    • Drug: Low molecular weight heparin
    • Device: Oxygen supply
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date May 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ANGEL MONTERO, Md, PhD +34667767601 angel.monteroluis@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04380818
Other Study ID Numbers  ICMJE IPACOVID
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual epidemiological and clinical data will be shared after recruitment is complete.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Protocol/ICF from approval Individual epidemiological and clinical data after recruitment is complete.
Responsible Party Grupo de Investigación Clínica en Oncología Radioterapia
Study Sponsor  ICMJE Grupo de Investigación Clínica en Oncología Radioterapia
Collaborators  ICMJE
  • Hospital Universitario Madrid Sanchinarro
  • Hospital del Mar
  • Hospital Universitari Sant Joan de Reus
Investigators  ICMJE
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
PRS Account Grupo de Investigación Clínica en Oncología Radioterapia
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP