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| Name | Class |
|---|---|
| Hospital Universitario Madrid Sanchinarro | OTHER |
| Hospital del Mar | OTHER |
| Hospital Universitari Sant Joan de Reus | OTHER |
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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.
Study design: This is a prospective multicenter study in 2 phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | a control group only receive pharmacological treatment |
|
| Experimental group | Experimental | an experimental group will receive low-dose lung irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose radiotherapy | Radiation | Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 2 after interventional radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Lung toxicity measured according to CTCAEv5 | Day 30 and day 90 after interventional radiotherapy |
| Change of the radiological image |
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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
Have read the information sheet and signed the informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANGEL MONTERO, Md, PhD | Contact | +34667767601 | angel.monteroluis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Angel Montero, MD, PhD | Hospital Universitario Madrid Sanchinarro | Principal Investigator |
| Manel Algara, MD, PhD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Reus | Not yet recruiting | Reus | Tarragona | 43204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32171193 | Background | 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. | |
| 23057008 | Background |
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Individual epidemiological and clinical data will be shared after recruitment is complete.
Protocol/ICF from approval Individual epidemiological and clinical data after recruitment is complete.
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| Hydroxychloroquine Sulfate | Drug | 200 mg/12h for 5 days |
|
|
| Ritonavir/lopinavir | Drug | 400/100 mg/12h for 7-10 days |
|
|
| Tocilizumab Injection [Actemra] | Drug | 600 mg/day for 1-2 doses |
|
|
| Azithromycin | Drug | 500 mg/24h for 3 days |
|
| Corticosteroid | Drug | Corticosteroids (methylprednisolone/dexamethasone/prednisone) |
|
| Low molecular weight heparin | Drug | low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism |
|
| Oxygen supply | Device | Oxygen |
|
Chest CT
| Days 7 and day 30 after interventional radiotherapy |
| Overall mortality | Death of any cause | Day 15 and Day 30 after interventional radiotherapy |
| Measure of pro-inflammatory interleukins | 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) | TGF-β (ng/ml) | Days 1, day 4 and day 7 after interventional radiotherapy |
| Measure of tumor necrosis factor alpha (TNF-a) | TNF-α (pg/ml) | Days 1, day 4 and day 7 after interventional radiotherapy |
| Determining overexpression of pro-inflammatory selectin | Overexpression of L-, E-, and P-selectin | Days 1, day 4 and day 7 after interventional radiotherapy |
| Determining cell adhesion molecules (CAMs) | Overexpression of ICAM-1, VCAM | Days 1, day 4 and day 7 after interventional radiotherapy |
| Measure of marker of oxidative stress PON-1 | PON-1(paraoxonase and arylesterase activity) (IU/ml) | Days 1, day 4 and day 7 after interventional radiotherapy |
| Merirxell Arenas, MD, PhD |
| Hospital Universitario Sant Joan de Reus |
| Principal Investigator |
| Hospital Del Mar | Not yet recruiting | Barcelona | 08003 | Spain |
|
| Hospital Universitario Madrid Sanchinarro | Recruiting | Madrid | 28050 | Spain |
|
| 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. |
| 22907572 | Background | 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. |
| 18031855 | Background | 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. |
| 22545750 | Background | 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. |
| 24348219 | Background | 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. |
| 31060383 | Background | 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. |
| 32342871 | Background | 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. |
| Background | 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. |
| 32437820 | Background | 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. |
| 32613089 | Derived | 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. |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D006886 | Hydroxychloroquine |
| C558899 | lopinavir-ritonavir drug combination |
| C502936 | tocilizumab |
| D017963 | Azithromycin |
| D000305 | Adrenal Cortex Hormones |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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