COVID-19 PneumoniaPhase 2NCT05694962
Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia
A Phase 2 study testing Low-Dose Radiation Therapy in people with COVID-19 Pneumonia, run by Jiangsu Cancer Institute & Hospital.
Trial summary
This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Low-Dose Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2024
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a positive test confirming the diagnosis of COVID-19;
- Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment);
- Have visible consolidations/ground glass opacities on chest x-ray or computed tomography;
- Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy;
- They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.
Who cannot join
- Have received chest radiotherapy before
- Bacteria, fungi and other infections other than novel coronavirus infection;
- Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST> normal reference value, the upper limit of Scr> normal reference value, poor blood glucose control);
- Mental retardation, mental disorders;
- Planned pregnancy, pregnancy, lactation women and during the trial;
- Allergy constitution or allergy to the drug ingredients and excipients of this test;
- Participated in other clinical trials in the recent 1 month;
- The Investigator does not considered appropriate to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1.5Gy of single low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Low-Dose Radiation Therapy
- Keywords
- COVID-19, Radiation Therapy, Pneumonia
- 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.
Low-Dose Radiation TherapyRadiation
1.5Gy single treatment of whole-lung radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy Receives: Radiation: Low-Dose Radiation Therapy |
| Control group | No intervention | supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
improvement of oxygen saturation in percentage
Measured: 28 days after radiation therapy
Secondary outcomes (10)
Temperature
Temperature in degrees (˚C)
Measured: 28 days after radiation therapy
Heart Rate
Heart rate in beats per minutes
Measured: 28 days after radiation therapy
Systolic blood pressure
Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg
Measured: 28 days after radiation therapy
Respirations Respirations Respirations Respirations Respirations Respirations
Respiratory rate in breaths per minute
Measured: 28 days after radiation therapy
FiO2
Fi02 in percentage
Measured: 28 days after radiation therapy
PEEP Tidal volume Tidal volume
Positive end expiratory pressure (PEEP) in cm H20
Measured: 28 days after radiation therapy
Overall survival Overall survival
Survival in percentage
Measured: 28 days after radiation therapy
Chest CT can
CT scans with volume of consolidation measured in cubic centimeters
Measured: 28 days after radiation therapy
Blood Test
Measured: 28 days after radiation therapy
Urine Test
Measured: 28 days after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Chest Hospital, Nanjing Medical University, Central South University, Zhongda Hospital
- Responsible party
- Principal investigator, Dr. He Xia, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694962
- Sponsor's protocol ID
- LDRT-SCov19
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05694962
- Acronym / sponsor ID
- LDRT-SCov19
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, Radiation Therapy, Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Collaborators
- Nanjing Chest Hospital, Nanjing Medical University, Central South University, Zhongda Hospital
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Jan 2023 (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.
This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.
Detailed description
PRIMARY OBJECTIVE:
- To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy
OUTLINE:
Patients undergo 1.5Gy of single low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Radiation: Low-Dose Radiation Therapysupportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy |
| Control group | No intervention | –supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have had a positive test confirming the diagnosis of COVID-19;
- Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment);
- Have visible consolidations/ground glass opacities on chest x-ray or computed tomography;
- Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy;
- They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.
Key exclusion criteria (8 listed)
- Have received chest radiotherapy before
- Bacteria, fungi and other infections other than novel coronavirus infection;
- Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST> normal reference value, the upper limit of Scr> normal reference value, poor blood glucose control);
- Mental retardation, mental disorders;
- Planned pregnancy, pregnancy, lactation women and during the trial;
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 Radiation Therapy1.5Gy single treatment of whole-lung radiation therapy | Radiation | Treatment group |
Primary outcome
Clinical improvement
Time frame: 28 days after radiation therapy
improvement of oxygen saturation in percentage
10 secondary outcomes
Temperature
Time frame: 28 days after radiation therapy
Heart Rate
Time frame: 28 days after radiation therapy
Systolic blood pressure
Time frame: 28 days after radiation therapy
Respirations Respirations Respirations Respirations Respirations Respirations
Time frame: 28 days after radiation therapy
FiO2
Time frame: 28 days after radiation therapy
PEEP Tidal volume Tidal volume
Time frame: 28 days after radiation therapy
Overall survival Overall survival
Time frame: 28 days after radiation therapy
Chest CT can
Time frame: 28 days after radiation therapy
Blood Test
Time frame: 28 days after radiation therapy
Urine Test
Time frame: 28 days after radiation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-Dose Radiation Therapy in people with COVID-19 Pneumonia, run by Jiangsu Cancer Institute & Hospital.
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 5 inclusion and 8 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lirong Wu, M.D, Ph.D (13701588737, wulirong126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 28 days after radiation therapy). 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 25 Jan 2023.