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Status unknownNCT04380818Updated Jul 30, 2021

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

An interventional study of Low-dose radiotherapy and Hydroxychloroquine Sulfate in Pneumonia, Viral, sponsored by Grupo de Investigación Clínica en Oncología Radioterapia. Status unknown at 3 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Grupo de Investigación Clínica en Oncología Radioterapia · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
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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.

Read the 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.
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Conditions studied

  • Pneumonia, Viral

Keywords

  • COVID 19
  • RADIATION
  • Anti-inflammatory effects
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 106 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Grupo de Investigación Clínica en Oncología Radioterapia is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Age \<18 years
  • Failure to meet the inclusion criteria
  • Leukopenia \<1000
  • Pregnancy
  • Not understanding or refusing the purpose of the study
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (estimated)

Study arms

  • Active comparator
    Control group

    a control group only receive pharmacological treatment

    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

    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

Interventions

  • RadiationLow-dose radiotherapy

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

  • DrugHydroxychloroquine Sulfate

    200 mg/12h for 5 days

    Also known as: Dolquine

  • DrugRitonavir/lopinavir

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

    Also known as: Kaletra

  • DrugTocilizumab Injection [Actemra]

    600 mg/day for 1-2 doses

    Also known as: Actemra

  • DrugAzithromycin

    500 mg/24h for 3 days

  • DrugCorticosteroid

    Corticosteroids (methylprednisolone/dexamethasone/prednisone)

  • DrugLow molecular weight heparin

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

  • DeviceOxygen supply

    Oxygen

06

What researchers measure

Primary outcomes

  1. Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%

    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

    Time frame: Day 2 after interventional radiotherapy

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Lung toxicity measured according to CTCAEv5

    Time frame: Day 30 and day 90 after interventional radiotherapy

  2. Change of the radiological image

    Chest CT

    Time frame: Days 7 and day 30 after interventional radiotherapy

  3. Overall mortality

    Death of any cause

    Time frame: Day 15 and Day 30 after interventional radiotherapy

  4. Measure of pro-inflammatory interleukins

    Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

  5. Measure of trasforming growth factor (TGF-b)

    TGF-β (ng/ml)

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

  6. Measure of tumor necrosis factor alpha (TNF-a)

    TNF-α (pg/ml)

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

  7. Determining overexpression of pro-inflammatory selectin

    Overexpression of L-, E-, and P-selectin

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

  8. Determining cell adhesion molecules (CAMs)

    Overexpression of ICAM-1, VCAM

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

  9. Measure of marker of oxidative stress PON-1

    PON-1(paraoxonase and arylesterase activity) (IU/ml)

    Time frame: Days 1, day 4 and day 7 after interventional radiotherapy

07

Study locations

1 of 3 sites recruiting
  • Hospital Sant Joan de Reus
    Reus, Tarragona 43204, Spain
    Not yet recruiting
  • Hospital Del Mar
    Barcelona, 08003, Spain
    Not yet recruiting
  • Hospital Universitario Madrid Sanchinarro
    Madrid, 28050, Spain
    Recruiting
08

References and documents

Publications

  • Conti P, Ronconi G, Caraffa A, Gallenga CE, Ross R, Frydas I, Kritas SK. Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies. J Biol Regul Homeost Agents. 2020 March-April,;34(2):327-331. doi: 10.23812/CONTI-E. PubMed 32171193 ↗
  • Rodel F, Frey B, Manda K, Hildebrandt G, Hehlgans S, Keilholz L, Seegenschmiedt MH, Gaipl US, Rodel C. Immunomodulatory properties and molecular effects in inflammatory diseases of low-dose x-irradiation. Front Oncol. 2012 Sep 25;2:120. doi: 10.3389/fonc.2012.00120. eCollection 2012. PubMed 23057008 ↗
  • Arenas M, Sabater S, Hernandez V, Rovirosa A, Lara PC, Biete A, Panes J. Anti-inflammatory effects of low-dose radiotherapy. Indications, dose, and radiobiological mechanisms involved. Strahlenther Onkol. 2012 Nov;188(11):975-81. doi: 10.1007/s00066-012-0170-8. Epub 2012 Aug 22. PubMed 22907572 ↗
  • Arenas M, Gil F, Gironella M, Hernandez V, Biete A, Pique JM, Panes J. Time course of anti-inflammatory effect of low-dose radiotherapy: correlation with TGF-beta(1) expression. Radiother Oncol. 2008 Mar;86(3):399-406. doi: 10.1016/j.radonc.2007.10.032. Epub 2007 Nov 26. PubMed 18031855 ↗
  • Lodermann B, Wunderlich R, Frey S, Schorn C, Stangl S, Rodel F, Keilholz L, Fietkau R, Gaipl US, Frey B. Low dose ionising radiation leads to a NF-kappaB dependent decreased secretion of active IL-1beta by activated macrophages with a discontinuous dose-dependency. Int J Radiat Biol. 2012 Oct;88(10):727-34. doi: 10.3109/09553002.2012.689464. Epub 2012 May 22. PubMed 22545750 ↗
  • Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70. PubMed 24348219 ↗
  • Calabrese EJ, Dhawan G, Kapoor R, Kozumbo WJ. Radiotherapy treatment of human inflammatory diseases and conditions: Optimal dose. Hum Exp Toxicol. 2019 Aug;38(8):888-898. doi: 10.1177/0960327119846925. Epub 2019 May 6. PubMed 31060383 ↗
  • Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. No abstract available. PubMed 32342871 ↗
  • Jean-Marc Cosset, Éric Deutsch, Louis Bazire, Jean-Jacques Mazeron, Cyrus Chargari, Irradiation pulmonaire à faible dose pour l'orage de cytokines du covid-19: pourquoi pas?, Cancer/Radiothérapie, 2020, , ISSN 1278-3218, https://doi.org/10.1016/j.canrad.2020.04.003.
  • Dhawan G, Kapoor R, Dhawan R, Singh R, Monga B, Giordano J, Calabrese EJ. Low dose radiation therapy as a potential life saving treatment for COVID-19-induced acute respiratory distress syndrome (ARDS). Radiother Oncol. 2020 Jun;147:212-216. doi: 10.1016/j.radonc.2020.05.002. Epub 2020 May 8. PubMed 32437820 ↗
  • Algara M, Arenas M, Marin J, Vallverdu I, Fernandez-Leton P, Villar J, Fabrer G, Rubio C, Montero A. Low dose anti-inflammatory radiotherapy for the treatment of pneumonia by covid-19: A proposal for a multi-centric prospective trial. Clin Transl Radiat Oncol. 2020 Jun 15;24:29-33. doi: 10.1016/j.ctro.2020.06.005. eCollection 2020 Sep. PubMed 32613089 ↗

Individual participant data

Plan to share: Yes — Individual epidemiological and clinical data will be shared after recruitment is complete.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04380818
Lead sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Collaborators
Hospital Universitario Madrid Sanchinarro, Hospital del Mar, Hospital Universitari Sant Joan de Reus
Responsible party
Sponsor
First posted
May 8, 2020
Start date
Jun 5, 2020
Primary completion
Sep 4, 2021 (estimated)
Completion
Nov 1, 2021 (estimated)
Last update
Jul 30, 2021

Study contacts

ANGEL MONTERO, Md, PhD
Contact
angel.monteroluis@gmail.com
+34667767601
Angel Montero, MD, PhD
principal investigator · Hospital Universitario Madrid Sanchinarro
Manel Algara, MD, PhD
principal investigator · Hospital del Mar
Merirxell Arenas, MD, PhD
principal investigator · Hospital Universitario Sant Joan de Reus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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