Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
NCT ID: NCT04380818
Last Updated: 2021-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2020-06-05
2021-11-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group
a control group only receive pharmacological treatment
Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Ritonavir/lopinavir
400/100 mg/12h for 7-10 days
Tocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
Azithromycin
500 mg/24h for 3 days
Corticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Low molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Oxygen supply
Oxygen
Experimental group
an experimental group will receive low-dose lung irradiation
Low-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Ritonavir/lopinavir
400/100 mg/12h for 7-10 days
Tocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
Azithromycin
500 mg/24h for 3 days
Corticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Low molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Oxygen supply
Oxygen
Interventions
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Low-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Ritonavir/lopinavir
400/100 mg/12h for 7-10 days
Tocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
Azithromycin
500 mg/24h for 3 days
Corticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Low molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Oxygen supply
Oxygen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Leukopenia \<1000
* Pregnancy
* Not understanding or refusing the purpose of the study
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Hospital Universitario Madrid Sanchinarro
OTHER
Hospital del Mar
OTHER
Hospital Universitari Sant Joan de Reus
OTHER
Grupo de Investigación Clínica en Oncología Radioterapia
OTHER
Responsible Party
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Principal Investigators
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Angel Montero, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Madrid Sanchinarro
Manel Algara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Merirxell Arenas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Sant Joan de Reus
Locations
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Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IPACOVID
Identifier Type: -
Identifier Source: org_study_id
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