PneumoniaLDCTiPNCT04379531
LDCT in COVID-19 Pneumonia: a Prospective Moscow Study
A study testing Low-dose Chest CT in people with Pneumonia and Coronavirus Infection, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
Trial summary
Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Coronavirus Infection
- What is being tested?
- Low-dose Chest CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteRussia
- Study dates
- 25 Apr 2020to 22 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A referral from the attending physician for a chest CT scan
- Suspected pneumonia
- Signed informed consent
- Over 18 years old
- Both male and female
Who cannot join
- Pregnant or nursing women
- Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
- Patients after surgical intervention at the level of the chest organs
- Cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Computed Tomography in COVID-19 Pneumonia: a Prospective Moscow Study
Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study.
Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during one visit to the computed tomography room.
Read the detailed description
As of 30 April 2020, there were over 3 million confirmed cases worldwide, of which over 200,000 were fatal. In Russia at the time of writing, 106 thousand cases of COVID-19 were registered in 78 regions, with 11619 recovered and 1073 dead. Initial prospective analysis of clinical data from 41 patients in Wuhan, with laboratory confirmation of the 2019-nCoV-2 virus, showed that 2019-nCoV-2 caused severe illness, clinically similar to SARS, which sometimes led to the need for hospitalization in the intensive care unit (13 out of 41 [32 %]) and death (6 out of 41 [15%]). All patients with pneumonia in this study had changes in the chest CT scan: preliminary reports indicated that all patients had bilateral lung infiltration.
Given the current prevalence of the disease and the nonspecific symptoms, we expect a significant increase in chest CT scans shortly. A low-dose chest CT scan can be performed with an effective dose of no more than 3.5 mSv, which is much lower than the dose received with a standard protocol - 8-10 mSv.
The investigators hypothesize that a patient with suspected pneumonia can have a low-dose chest CT scan instead of a standard CT while maintaining the accuracy of the method in the diagnosis of inflammatory pulmonary tissue infiltration. The advantage of participating in the study for the patient is the possibility of obtaining an image without motion artifacts that may be associated with coughing, possibly affecting the patient's management tactics.
The study is intended to provide answers to the following questions:
The primary point of the study is to evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. The expected correlation percentage is 90%.
The secondary point of study No. 1 is the threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan. Expected threshold - 10 mm.
The secondary point of study No.2 is the number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan. Expected number - more than two zones.
In the future, it is planned to use the obtained anonymized data to enter the international registers of images of pneumonia caused by COVID-19.
- Conditions
- Pneumonia, Coronavirus Infection
- Being tested
- Low-dose Chest CT
- Keywords
- Low-dose CT, Community-acquired pneumonia, Computed tomography
- Medical subject headings
- Pneumonia, Coronavirus Infections, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose Chest CTDiagnostic test
Patients referred by the primary care physician with suspected pneumonia.
| Study group | Role | What they receive |
|---|---|---|
| Standard Chest CT | Active comparator | Not described Receives: Diagnostic Test: Low-dose Chest CT |
| Low-dose Chest CT | Experimental | Not described Receives: Diagnostic Test: Low-dose Chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia.
A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.
Measured: Upon completion, up to 1 year
Secondary outcomes (2)
Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan.
Expected threshold - 10 mm.
Measured: Upon completion, up to 1 year
Number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan.
Expected number - more than two zones.
Measured: Upon completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start25 Apr 2020
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Morozov, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379531
- Sponsor's protocol ID
- 2020-1
- Acronym
- LDCTiP
- Status last verified
- May 2020
- First submitted
- 30 Apr 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Computed Tomography in COVID-19 Pneumonia: a Prospective Moscow Study
- ClinicalTrials.gov ID
- NCT04379531
- Acronym / sponsor ID
- LDCTiP / 2020-1
- Conditions
- Pneumonia, Coronavirus Infection
- Keywords
- Low-dose CT, Community-acquired pneumonia, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care DepartmentUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 7 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.
Hypothesis: low-dose chest computed tomography, has the same accuracy for the diagnosis of pneumonia compared to the routine protocol. In total, 230 patients are planned to be enrolled in the study.
Each patient will have 2 studies (routine chest CT and low-dose chest CT) sequentially during one visit to the computed tomography room.
Detailed description
As of 30 April 2020, there were over 3 million confirmed cases worldwide, of which over 200,000 were fatal. In Russia at the time of writing, 106 thousand cases of COVID-19 were registered in 78 regions, with 11619 recovered and 1073 dead. Initial prospective analysis of clinical data from 41 patients in Wuhan, with laboratory confirmation of the 2019-nCoV-2 virus, showed that 2019-nCoV-2 caused severe illness, clinically similar to SARS, which sometimes led to the need for hospitalization in the intensive care unit (13 out of 41 [32 %]) and death (6 out of 41 [15%]). All patients with pneumonia in this study had changes in the chest CT scan: preliminary reports indicated that all patients had bilateral lung infiltration.
Given the current prevalence of the disease and the nonspecific symptoms, we expect a significant increase in chest CT scans shortly. A low-dose chest CT scan can be performed with an effective dose of no more than 3.5 mSv, which is much lower than the dose received with a standard protocol - 8-10 mSv.
The investigators hypothesize that a patient with suspected pneumonia can have a low-dose chest CT scan instead of a standard CT while maintaining the accuracy of the method in the diagnosis of inflammatory pulmonary tissue infiltration. The advantage of participating in the study for the patient is the possibility of obtaining an image without motion artifacts that may be associated with coughing, possibly affecting the patient's management tactics.
The study is intended to provide answers to the following questions:
The primary point of the study is to evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. The expected correlation percentage is 90%.
The secondary point of study No. 1 is the threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan. Expected threshold - 10 mm.
The secondary point of study No.2 is the number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan. Expected number - more than two zones.
In the future, it is planned to use the obtained anonymized data to enter the international registers of images of pneumonia caused by COVID-19.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Chest CT | Active comparator | Diagnostic Test: Low-dose Chest CT |
| Low-dose Chest CT | Experimental | Diagnostic Test: Low-dose Chest CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A referral from the attending physician for a chest CT scan
- Suspected pneumonia
- Signed informed consent
- Over 18 years old
- Both male and female
Key exclusion criteria (4 listed)
- Pregnant or nursing women
- Presence of foreign implanted objects in the body at the scan level (including cardiac pacemakers, spine metalware)
- Patients after surgical intervention at the level of the chest organs
- Cancer patients
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 Chest CTPatients referred by the primary care physician with suspected pneumonia. | Diagnostic test | Low-dose Chest CT, Standard Chest CT |
Primary outcome
Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia.
Time frame: Upon completion, up to 1 year
A standardized scale CT1-CT4 will be used. The expected correlation percentage is 90%.
2 secondary outcomes
Threshold value of the infiltration zone size detected by low-dose CT scan compared to standard CT scan.
Time frame: Upon completion, up to 1 year
Number of infiltration zones of pulmonary parenchyma corresponding to viral pneumonia detected by low-dose CT scan in comparison with standard CT scan.
Time frame: Upon completion, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose Chest CT in people with Pneumonia and Coronavirus Infection, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
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 4 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: finished, as of the sponsor's last update on 12 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation between standard CT and low-dose CT scans for the detection of community-acquired pneumonia. (time frame: Upon completion, up to 1 year). 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 NCT04379531, which also lists 1 linked publication.
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 12 Jun 2020.