COVID-19NCT04933994
Comparison of COVID-19 and H1N1 Influenza Pneumonia
An observational study of COVID-19 and H1N1 Influenza, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, H1N1 Influenza
- What is being tested?
- computed Tomography
- Type of treatment
- Medical device
- How many people
- 483 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Sep 2020
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pneumonia with COVID-19 pneumonia or H1N1 influenza
Who may be able to join
- pneumonia
Who cannot join
- no pneumonia
About this study
Official title: Comparison of the Clinical and CT Features Between COVID-19 Pneumonia and H1N1 Influenza Pneumonia in Zhejiang, China
To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia.
Read the detailed description
COVID-19 pneumonia patients showed less proportions of underlying diseases, fever and respiratory symptoms than those of H1N1 pneumonia patients (p<0.01). White blood cell count, neutrophilic granulocyte percentage, C-reactive protein, procalcitonin, D-Dimer and lactate dehydrogenase in H1N1 pneumonia patients were higher than those of COVID-19 pneumonia patients (p<0.05). H1N1 pneumonia were often symmetrically located in the dorsal part of lung inferior lobes, while COVID-19 pneumonia were unsually showed a peripheral but non-specific lobe distributions. Ground glass opacity was more common in COVID-19 pneumonia and consolidation lesions was more common in H1N1 pneumonia (p<0.01). COVID-19 pneumonia lesions showed a relative clear margin compared with H1N1 pneumonia. Crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions were more common in COVID-19 pneumonia than H1N1 pneumonia (p<0.05). Pleural effusion in COVID-19 pneumonia was significantly less common than H1N1 pneumonia (p<0.01).
Compared with H1N1 pneumonia in Zhejiang, China, the clinical manifestations of COVID-19 pneumonia was more concealed with less underlying diseases and slighter respiratory symptoms. The more common CT manifestations of COVID-19 pneumonia included ground glass opacity with a relative clear margin, crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions, while the less common CT manifestations of COVID-19 pneumonia included consolidation and pleural effusion.
- Conditions
- COVID-19, H1N1 Influenza
- Being tested
- computed Tomography
- Keywords
- COVID-19, H1N1, Tomography, X-ray computed
- Medical subject headings
- COVID-19, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed TomographyDevice
All cases were detected with computed Tomography
| Study group | Role | What they receive |
|---|---|---|
| Coronavirus disease; Influenza A(H1N1) | two independent cohorts of COVID-19 pneumonia (n=405) and H1N1 influenza pneumonia (n=78) retrospectively, all patients were confirmed by RT-PCR. Four hundred and five cases of COVID-19 pneumonia were confirmed in nine hospitals of Zhejiang province, China from January 21 to February 20, 2020. Seventy-eight cases of H1N1 influenza pneumonia were confirmed in our hospital from January 1, 2017 to February 29, 2020. Receives: Device: computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the clinical and CT features between COVID-19 pneumonia and H1N1 influenza pneumonia in Zhejiang, China
one paper
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jan 2017
- Primary completion28 Feb 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 483 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yueqing People's Hospital of Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ruian People's Hospital of Zhejiang Province, Second Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, Kecheng People's Hospital of Quzhou city, Zhejiang Province, Pingyang People's Hospital of Zhejiang Province, The First People's Hospital of Yuhang District, Hangzhou, Zhejiang Province
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933994
- Sponsor's protocol ID
- 2021-0187
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical and CT Features Between COVID-19 Pneumonia and H1N1 Influenza Pneumonia in Zhejiang, China
- ClinicalTrials.gov ID
- NCT04933994
- Acronym / sponsor ID
- 2021-0187
- Conditions
- COVID-19, H1N1 Influenza
- Keywords
- COVID-19, H1N1, Tomography, X-ray computed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Yueqing People's Hospital of Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ruian People's Hospital of Zhejiang Province, Second Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, Kecheng People's Hospital of Quzhou city, Zhejiang Province, Pingyang People's Hospital of Zhejiang Province, The First People's Hospital of Yuhang District, Hangzhou, Zhejiang Province
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 22 Jun 2021 (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.
To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia.
Detailed description
COVID-19 pneumonia patients showed less proportions of underlying diseases, fever and respiratory symptoms than those of H1N1 pneumonia patients (p<0.01). White blood cell count, neutrophilic granulocyte percentage, C-reactive protein, procalcitonin, D-Dimer and lactate dehydrogenase in H1N1 pneumonia patients were higher than those of COVID-19 pneumonia patients (p<0.05). H1N1 pneumonia were often symmetrically located in the dorsal part of lung inferior lobes, while COVID-19 pneumonia were unsually showed a peripheral but non-specific lobe distributions. Ground glass opacity was more common in COVID-19 pneumonia and consolidation lesions was more common in H1N1 pneumonia (p<0.01). COVID-19 pneumonia lesions showed a relative clear margin compared with H1N1 pneumonia. Crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions were more common in COVID-19 pneumonia than H1N1 pneumonia (p<0.05). Pleural effusion in COVID-19 pneumonia was significantly less common than H1N1 pneumonia (p<0.01).
Compared with H1N1 pneumonia in Zhejiang, China, the clinical manifestations of COVID-19 pneumonia was more concealed with less underlying diseases and slighter respiratory symptoms. The more common CT manifestations of COVID-19 pneumonia included ground glass opacity with a relative clear margin, crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions, while the less common CT manifestations of COVID-19 pneumonia included consolidation and pleural effusion.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronavirus disease; Influenza A(H1N1) | – | Device: computed Tomographytwo independent cohorts of COVID-19 pneumonia (n=405) and H1N1 influenza pneumonia (n=78) retrospectively, all patients were confirmed by RT-PCR. Four hundred and five cases of COVID-19 pneumonia were confirmed in nine hospitals of Zhejiang province, China from January 21 to February 20, 2020. Seventy-eight cases of H1N1 influenza pneumonia were confirmed in our hospital from January 1, 2017 to February 29, 2020. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pneumonia with COVID-19 pneumonia or H1N1 influenza
Key inclusion criteria (1 listed)
- pneumonia
Key exclusion criteria (1 listed)
- no pneumonia
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 |
|---|---|---|
| computed TomographyAll cases were detected with computed Tomography | Device | Coronavirus disease; Influenza A(H1N1) |
Primary outcome
Comparison of the clinical and CT features between COVID-19 pneumonia and H1N1 influenza pneumonia in Zhejiang, China
Time frame: 1 year
one paper
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 16 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and H1N1 Influenza, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 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: finished, as of the sponsor's last update on 16 Jul 2021. 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.
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?
Comparison of the clinical and CT features between COVID-19 pneumonia and H1N1 influenza pneumonia in Zhejiang, China (time frame: 1 year). 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 16 Jul 2021.