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Covid19LOWRAD-Cov19NCT04420390

Low Dose Radiotherapy for COVID-19 Pneumonitis

A study testing Radiotherapy in people with Covid19, run by Hospital San Carlos, Madrid at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality. The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Covid19
What is being tested?
Radiotherapy
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 May 2020to 8 Sep 2020
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60 years.
  • COVID19 + confirmed by PCR.
  • Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement.
  • Phase II or lung phase without any improvement with pharmacological treatment.
  • Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment
  • Poor clinical and functional respiratory evolution: > 30 breaths / minute, SpO2 <93%, PaO2 / FiO2 <300.
  • D-dimer> 1000 ng / mL or rising, ferritin> 1000 ng / mL, PCR> 10 mg / dL or double than before.

Who cannot join

  • 1. Severe comorbidities that could hamper the radiation treatment.

Trial locations and contacts

1 site in 1 country.

Manuel Gonzalo Vazquez Masedo, MD,PhD contact

913003000

manuelgonzalo.vazquez@salud.madrid.org

Spain1 site, 1 recruiting

  • Servicio de Oncología Radioterápica. Hospital Clínico San Carlos

    Madrid, 28040

    Manuel Gonzalo Vazquez Masedo, MD, PhD, 913003000, manuelgonzalo.vazquez@salud.madrid.org

    Recruiting

Other trials in Spain

About this study

Official title: Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis

SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality.

The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.

Conditions
Covid19
Being tested
Radiotherapy
Keywords
Radiotherapy, Antiinflammatory, Pneumonitis
Medical subject headings
COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    Low-dose radiotherapy

Study groups in NCT04420390
Study groupRoleWhat they receive
RadiotherapyExperimentalNot described
Receives: Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological response

    Radiological results: Radiological worsening, improvement or without significant changes

    Measured: 3 days after low dose radiation

  2. Radiological response

    Radiological results: Radiological worsening, improvement or without significant changes

    Measured: 7 days after low dose radiation

Secondary outcomes (20)

  1. Remission of respiratory symptoms

    Remission of respiratory symptoms

    Measured: up to 6 months

  2. SPO2 and PaO2/FiO2

    Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen

    Measured: 7 days

  3. Adverse events

    Occurrence and grade of CTCAE 5.0 adverse events

    Measured: 1 year

  4. Hospitalization

    Duration of hospitalization

    Measured: 3 months

  5. Overall survival

    Overall survival

    Measured: 1 month

  6. Ferritin value

    ferritin value (ng/mL)

    Measured: 1 day after low dose radiation

  7. Ferritin value

    ferritin value (ng/mL)

    Measured: 2 days after low dose radiation

  8. Ferritin value

    ferritin value (ng/mL)

    Measured: 3 days after low dose radiation

  9. blood cell count

    blood cell count (unit/L)

    Measured: 1 day after low dose radiation

  10. blood cell count

    blood cell count (unit/L)

    Measured: 2 days after low dose radiation

  11. blood cell count

    blood cell count (unit/L)

    Measured: 3 days after low dose radiation

  12. C-reactive protein

    C-reactive protein (mg/dl)

    Measured: 1 day after low dose radiation

  13. C-reactive protein

    C-reactive protein (mg/dl)

    Measured: 2 days after low dose radiation

  14. C-reactive protein

    C-reactive protein (mg/dl)

    Measured: 3 days after low dose radiation

  15. D-dimer

    D-dimer (ng/ml)

    Measured: 1 day after low dose radiation

  16. D-dimer

    D-dimer (ng/ml)

    Measured: 2 days after low dose radiation

  17. D-dimer

    D-dimer (ng/ml)

    Measured: 3 days after low dose radiation

  18. LDH levels

    LDH levels (UI/L)

    Measured: 1 day after low dose radiation

  19. LDH levels

    LDH levels (UI/L)

    Measured: 2 days after low dose radiation

  20. LDH levels

    LDH levels (UI/L)

    Measured: 3 days after low dose radiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start1 May 2020
  3. Primary completion31 Jul 2020 (estimated)
  4. Study completion8 Sep 2020 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420390
Sponsor's protocol ID
LOWRAD-Cov19
Acronym
LOWRAD-Cov19
Status last verified
Jun 2020
First submitted
14 May 2020
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiotherapy in people with Covid19, run by Hospital San Carlos, Madrid 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 7 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 9 Jun 2020. 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 Manuel Gonzalo Vazquez Masedo, MD,PhD (913003000, manuelgonzalo.vazquez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological response (time frame: 3 days after low dose radiation). 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?

On the ClinicalTrials.gov record for NCT04420390.

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 9 Jun 2020.

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