Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
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ClinicalTrials.gov Identifier: NCT04380818 |
Recruitment Status :
Recruiting
First Posted : May 8, 2020
Last Update Posted : July 30, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia, Viral | 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 | Not Applicable |
Study design: This is a prospective multicenter study in 2 phases:
- 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.
- 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 (Clinical Trial) |
Estimated Enrollment : | 106 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study |
Actual Study Start Date : | June 5, 2020 |
Estimated Primary Completion Date : | September 4, 2021 |
Estimated Study Completion Date : | November 1, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Control group
a control group only receive pharmacological treatment
|
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 |
Experimental: Experimental group
an experimental group will receive low-dose lung irradiation
|
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 |
- 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
- 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)

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380818
Contact: ANGEL MONTERO, Md, PhD | +34667767601 | angel.monteroluis@gmail.com |
Spain | |
Hospital Sant Joan de Reus | Not yet recruiting |
Reus, Tarragona, Spain, 43204 | |
Contact: MERITXELL ARENAS, MD, PhD meritxell.arenas@gmail.com | |
Hospital Del Mar | Not yet recruiting |
Barcelona, Spain, 08003 | |
Contact: MANEL ALGARA, MD, PhD MAlgara@parcdesalutmar.cat | |
Hospital Universitario Madrid Sanchinarro | Recruiting |
Madrid, Spain, 28050 | |
Contact: Angel Montero, MD, PhD +34915629949 amontero@hmhospitales.com |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Grupo de Investigación Clínica en Oncología Radioterapia |
ClinicalTrials.gov Identifier: | NCT04380818 |
Other Study ID Numbers: |
IPACOVID |
First Posted: | May 8, 2020 Key Record Dates |
Last Update Posted: | July 30, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual epidemiological and clinical data will be shared after recruitment is complete. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Protocol/ICF from approval Individual epidemiological and clinical data after recruitment is complete. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID 19 RADIATION Anti-inflammatory effects |
COVID-19 Pneumonia Pneumonia, Viral Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ritonavir Lopinavir Azithromycin |
Hydroxychloroquine Heparin Heparin, Low-Molecular-Weight Tinzaparin Dalteparin HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors |