Pneumonia, ViralNCT04380818
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
A study testing Low-dose radiotherapy, Hydroxychloroquine Sulfate and Ritonavir/lopinavir in people with Pneumonia, Viral, run by Grupo de Investigación Clínica en Oncología Radioterapia at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pneumonia, Viral
- What is being tested?
- Low-dose radiotherapy, Hydroxychloroquine Sulfate and Ritonavir/lopinavir
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesSpain
- Study dates
- 5 Jun 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- or PCR> 100mg / l
- D-dimer greater than 1500ng / ml
- Suspected cytokine release syndrome
- Have read the information sheet and signed the informed consent
Who cannot join
- Age <18 years
- Failure to meet the inclusion criteria
- Leukopenia <1000
- Pregnancy
- Not understanding or refusing the purpose of the study
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Del Mar
Barcelona, 08003
MANEL ALGARA, MD, PhD, MAlgara@parcdesalutmar.cat
- Recruiting
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Angel Montero, MD, PhD, +34915629949, amontero@hmhospitales.com
- Not yet recruiting
Hospital Sant Joan de Reus
Reus, Tarragona, 43204
MERITXELL ARENAS, MD, PhD, meritxell.arenas@gmail.com
About this study
Official title: Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
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:
- 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.
- Conditions
- Pneumonia, Viral
- Being tested
- Low-dose radiotherapy, Hydroxychloroquine Sulfate, Ritonavir/lopinavir, Tocilizumab Injection [Actemra], Azithromycin
- Keywords
- COVID 19, RADIATION, Anti-inflammatory effects
- Medical subject headings
- Pneumonia, Viral, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose radiotherapyRadiation
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
Hydroxychloroquine SulfateDrug
Also called Dolquine
200 mg/12h for 5 days
Ritonavir/lopinavirDrug
Also called Kaletra
400/100 mg/12h for 7-10 days
Tocilizumab Injection [Actemra]Drug
Also called Actemra
600 mg/day for 1-2 doses
AzithromycinDrug
500 mg/24h for 3 days
CorticosteroidDrug
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Low molecular weight heparinDrug
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Oxygen supplyDevice
Oxygen
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | a control group only receive pharmacological treatment Receives: Drug: Hydroxychloroquine Sulfate; Drug: Ritonavir/lopinavir; Drug: Tocilizumab Injection [Actemra]; Drug: Azithromycin; Drug: Corticosteroid; Drug: Low molecular weight heparin; Device: Oxygen supply |
| Experimental group | Experimental | an experimental group will receive low-dose lung irradiation Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 2 after interventional radiotherapy
Secondary outcomes (9)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Lung toxicity measured according to CTCAEv5
Measured: Day 30 and day 90 after interventional radiotherapy
Change of the radiological image
Chest CT
Measured: Days 7 and day 30 after interventional radiotherapy
Overall mortality
Death of any cause
Measured: 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)
Measured: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of trasforming growth factor (TGF-b)
TGF-β (ng/ml)
Measured: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of tumor necrosis factor alpha (TNF-a)
TNF-α (pg/ml)
Measured: Days 1, day 4 and day 7 after interventional radiotherapy
Determining overexpression of pro-inflammatory selectin
Overexpression of L-, E-, and P-selectin
Measured: Days 1, day 4 and day 7 after interventional radiotherapy
Determining cell adhesion molecules (CAMs)
Overexpression of ICAM-1, VCAM
Measured: 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)
Measured: Days 1, day 4 and day 7 after interventional radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start5 Jun 2020
- Primary completion4 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Madrid Sanchinarro, Hospital del Mar, Hospital Universitari Sant Joan de Reus
- Responsible party
- Sponsor
- Investigators
- Angel Montero, MD, PhD, Principal investigator, Hospital Universitario Madrid SanchinarroManel Algara, MD, PhD, Principal investigator, Hospital del MarMerirxell Arenas, MD, PhD, Principal investigator, Hospital Universitario Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380818
- Sponsor's protocol ID
- IPACOVID
- Status last verified
- Jul 2021
- First submitted
- 4 May 2020
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual epidemiological and clinical data will be shared after recruitment is complete.
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 32171193Rodel 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 23057008Arenas 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 22907572Arenas 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 18031855Lodermann 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 22545750Calabrese 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 24348219Calabrese 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 31060383Kirkby 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 32342871Jean-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 32437820Algara 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
- ClinicalTrials.gov ID
- NCT04380818
- Acronym / sponsor ID
- IPACOVID
- Conditions
- Pneumonia, Viral
- Keywords
- COVID 19, RADIATION, Anti-inflammatory effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Collaborators
- Hospital Universitario Madrid Sanchinarro, Hospital del Mar, Hospital Universitari Sant Joan de Reus
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 4 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Hydroxychloroquine Sulfate, Drug: Ritonavir/lopinavir, Drug: Tocilizumab Injection [Actemra], Drug: Azithromycin, Drug: Corticosteroid, Drug: Low molecular weight heparin, Device: Oxygen supplya control group only receive pharmacological treatment |
| Experimental group | Experimental | 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 supplyan experimental group will receive low-dose lung irradiation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- Age <18 years
- Failure to meet the inclusion criteria
- Leukopenia <1000
- Pregnancy
- Not understanding or refusing the purpose of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose radiotherapyBilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later | Radiation | Experimental group |
| Hydroxychloroquine SulfateAlso: Dolquine200 mg/12h for 5 days | Drug | Control group, Experimental group |
| Ritonavir/lopinavirAlso: Kaletra400/100 mg/12h for 7-10 days | Drug | Control group, Experimental group |
| Tocilizumab Injection [Actemra]Also: Actemra600 mg/day for 1-2 doses | Drug | Control group, Experimental group |
| Azithromycin500 mg/24h for 3 days | Drug | Control group, Experimental group |
| CorticosteroidCorticosteroids (methylprednisolone/dexamethasone/prednisone) | Drug | Control group, Experimental group |
| Low molecular weight heparinlow molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism | Drug | Control group, Experimental group |
| Oxygen supplyOxygen | Device | Control group, Experimental group |
Primary outcome
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
9 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 30 and day 90 after interventional radiotherapy
Change of the radiological image
Time frame: Days 7 and day 30 after interventional radiotherapy
Overall mortality
Time frame: Day 15 and Day 30 after interventional radiotherapy
Measure of pro-inflammatory interleukins
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of trasforming growth factor (TGF-b)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of tumor necrosis factor alpha (TNF-a)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Determining overexpression of pro-inflammatory selectin
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Determining cell adhesion molecules (CAMs)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of marker of oxidative stress PON-1
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 32171193Conti 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.
- Background: PubMed 23057008Rodel 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.
- Background: PubMed 22907572Arenas 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.
- Background: PubMed 18031855Arenas 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.
- Background: PubMed 22545750Lodermann 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.
- Background: PubMed 24348219Calabrese 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.
- Background: PubMed 31060383Calabrese 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.
- Background: PubMed 32342871Kirkby 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.
- BackgroundJean-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.
- Background: PubMed 32437820Dhawan 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.
- Derived from this study: PubMed 32613089Algara 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.
- Individual participant dataSharing planned: Yes. Individual epidemiological and clinical data will be shared after recruitment is complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose radiotherapy, Hydroxychloroquine Sulfate and Ritonavir/lopinavir in people with Pneumonia, Viral, run by Grupo de Investigación Clínica en Oncología Radioterapia at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANGEL MONTERO, Md, PhD (+34667767601, angel.monteroluis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20% (time frame: Day 2 after interventional radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380818, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.