COVIDCOVRTE-19NCT04414293
Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
A study testing Lung Low Dose Radiation in people with COVID and Pneumonia, Viral, run by Hospital Provincial de Castellon at 1 site in Spain.
Trial summary
The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response. The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COVID, Pneumonia, Viral
- What is being tested?
- Lung Low Dose Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years old
- Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:
- Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).
- Acute respiratory failure expressed by PaO2 / FIO2 <300.
- Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).
- Patients with ≤8 days from the onset of symptoms.
Who cannot join
- Patient not consent to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Provincial de Castellon
Castellon, Castellon, 12002
FRANCISCO GARCIA PINON, MSc, 964354458
Carlos Ferrer Albiach, MD
About this study
Official title: Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU
Read the detailed description
The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".
Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.
Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.
The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.
This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.
- Conditions
- COVID, Pneumonia, Viral
- Being tested
- Lung Low Dose Radiation
- Keywords
- covid-19 pneumonia, Low dose Radiotherapy
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Low Dose RadiationRadiation
The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All the patients will be treated with low dose lung radiation Receives: Radiation: Lung Low Dose Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood oxygen saturation level
Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
Measured: 48 hours
Torax X-ray
radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
Measured: 48 hours
Secondary outcomes (3)
Hospitalization
number of days of hospital stay.
Measured: 2 months
days free of assisted mechanical respiration
Number of days free of assisted mechanical respiration.
Measured: 3 month
Mortality
number of deaths
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Oct 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Provincial de Castellon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Ferrer Albiach, Hospital Provincial de Castellon
- Investigators
- Carlos Ferrer Albiach, MD, Principal investigator, Hospital Provincial de Castellon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414293
- Sponsor's protocol ID
- FHPCS-20-001
- Acronym
- COVRTE-19
- Status last verified
- Feb 2021
- First submitted
- 1 Jun 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
- ClinicalTrials.gov ID
- NCT04414293
- Acronym / sponsor ID
- COVRTE-19 / FHPCS-20-001
- Conditions
- COVID, Pneumonia, Viral
- Keywords
- covid-19 pneumonia, Low dose Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Hospital Provincial de CastellonUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Jun 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.
The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU
Detailed description
The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".
Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.
Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.
The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.
This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Lung Low Dose RadiationAll the patients will be treated with low dose lung radiation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients over 65 years old
- Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:
Key exclusion criteria (1 listed)
- Patient not consent to participate
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 |
|---|---|---|
| Lung Low Dose RadiationThe administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response. | Radiation | Treatment |
Primary outcome
blood oxygen saturation level
Time frame: 48 hours
Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
Torax X-ray
Time frame: 48 hours
radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
3 secondary outcomes
Hospitalization
Time frame: 2 months
days free of assisted mechanical respiration
Time frame: 3 month
Mortality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
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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.
Carlos Ferrer Albiach, MD principal investigator
Hospital Provincial de Castellon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Low Dose Radiation in people with COVID and Pneumonia, Viral, run by Hospital Provincial de Castellon at 1 site 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 6 inclusion and 1 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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Francisco Garcia Piñón, MSc (964354458, francisco.garpi@hospitalprovincial.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood oxygen saturation level (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.