Official Title
Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients
Brief Summary

The investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to compare the radiological patterns found in patients with COVID-19 and influenza H1N1. The secondary aims of this study will assess the association between the radiological CT pattern and the need for invasive mechanical ventilation and mortality within the first 28 days of intensive care unit admission.

Detailed Description

Background

In late 2019, a new coronavirus was linked to several cases of pneumonia in the city of
Wuhan, Hubei province, China. On February 11, 2020, the World Health Organization (WHO)
designated COVID-19 a pandemic disease. The mortality associated with COVID-19 patients that
required management in a critical care unit is approximately 4.3%. COVID-19 is caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diagnosis of COVID-19 is made
with a positive test (i.e. reverse transcriptase-polymerase chain reaction, RT-PCR) from a
person with clinical signs and symptoms of a respiratory tract infection. Viral pneumonia is
currently a challenge worldwide as it is associated with high morbidity and mortality. In
June of 2009, the WHO declared influenza A H1N1 a pandemic disease. Worldwide, influenza H1N1
had a mortality of 11%, with a higher mortality rate among people older than 50 years of age
(i.e. 18-20%). Influenza diagnosis can be established using RT-PCR. Around 200 million cases
of community-acquired viral pneumonia occur each year worldwide, 100 million in children, and
100 million in adults. Imaging findings in viral pneumonia are diverse and overlap with
findings associated with non-viral infections and inflammatory conditions. However,
identifying the underlying viral pathogens may not always be easy. Several imaging patterns
have been described in association with these viruses. Although a definitive diagnosis cannot
be achieved based on imaging studies, imaging pattern recognition of viral pneumonia can help
differentiate between viral and bacterial pathogens; thus, reducing the use of indiscriminate
antibiotics. There are few studies that correlate tomographic findings in patients with viral
infections in the lower respiratory tract.

The use of computed tomography (CT) should be considered as the first option for diagnostic
imaging in patients with suspected pneumonia. Peripheral multifocal ground glass patterns
with irregular consolidation images found in the lower lobes or posteriorly in pulmonary CT
scans have been described in patients with viral pneumonia due to SARS-CoV-2. Furthermore,
complicating the diagnosis of atypical viral pneumonia, 17.9% of mild COVID-19 and 2.9% of
moderate-severe COVID-19 patients did not have CT evidence of pneumonia upon hospital
admission. One recent study compared the CT radiological patterns found in COVID-19 pneumonia
to other viral pneumonias (i.e. influenza, parainfluenza, adenovirus, and respiratory
syncytial virus) reporting higher peripheral distribution (i.e. 80% vs. 57%, p<0.001), more
ground-glass opacities (i.e. 91% vs 68%, p<0.001), greater frequency of fine reticular
opacities (i.e. 56% vs. 22%, p<0.001), and vascular thickening in COVID-19 patients;
meanwhile, other viral pneumonias were more likely to have a mixed distribution pattern(i.e.
35% vs. 14%, p<0.001), have pleural effusion (i.e. 39% vs. 4.1%, p<0.001), and present
visible lymph nodes (10.2% vs. 2.7%, p<0.001). Another study compared the pulmonary
radiological patterns associated with COVID-19 compared to influenza (A and B) reporting
higher round opacities (i.e. 35% vs. 17%, p=0.048) and greater frequency of interlobular
septal thickening (i.e. 66% vs. 43%, p=0.014) in patients with COVID-19; conversely,
influenza patients had a higher frequency of nodular lesions (i.e. 71% vs. 28%, p<0.001),
higher frequency of small dense nodular lesions (i.e. 40% vs. 9%, p<0.001), and more likely
to have pleural effusion (i.e. 31% vs. 6%, p<0.001).

Research questions

1. What are the pulmonary tomographic findings in patients diagnosed with
community-acquired pneumonia secondary to SARS-CoV-2?

2. What are the pulmonary tomographic findings in patients diagnosed with
community-acquired pneumonia secondary to H1N1 influenza?

3. Are the 28-day survival distributions different for SARS-CoV-2 and H1N1 influenza?

4. Is there a difference in the 28-day survival distribution and the pulmonary tomographic
radiological patterns in patients with pneumonia secondary to SARS-CoV-2?

5. Is there a difference in the 28-day survival distribution and the pulmonary tomographic
radiological patterns in patients with pneumonia secondary to H1N1 influenza?

6. What factors are associated with the survival differences in 28-day mortality in both
groups and between groups?

Unknown status
SARS-CoV-2
COVID19
H1N1 Influenza
Computed Tomography

Diagnostic Test: Thoraxic computed tomography

Diagnostic lung CT.

Eligibility Criteria

Inclusion Criteria:

- Patients with signed informed consent.

- Patients with a positive PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency
department admission.

- Patients with lung CT within 24hrs of specimen collection for PCR test.

- Patients with complete 30-day follow-up information.

Exclusion Criteria:

- Patients who are unwilling to undergo a lung CT.

- Negative PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency department
admission.

- Patients with a tumor or tumor metastasis on the pulmonary CT.

- Patients with a previous or de novo autoimmune disease diagnosis.

- Patients with a previous or de novo interstitial lung disease.

- Pregnancy.

Elimination Criteria:

- Patients with loss of information on the variables of interest.

- Patients without 30-day follow-up information.

- Patients who chose to withdraw their participation at any time of the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Mexico
Locations

Hospital General León-Milenio
León, Guanajuato, Mexico

Investigator: Lourdes N Veléz-Ramírez, M.D.
Contact: +52 477 719 7400
nestlynoemi@gmail.com

Contacts

Lourdes N Vélez-Ramírez, M.D.
+52 477 719 7400
nestlynoemi@gmail.com

Omar Jiménez-Zarazúa, M.D.
+52 4421377672
drzarazuainterna@hotmail.com

Omar Jiménez-Zarazúa, M.D., Principal Investigator
Medical researcher, Internist

Universidad de Guanajuato
NCT Number
Keywords
Radiological patterns
28-day survival
MeSH Terms
COVID-19
Influenza, Human