Tomographic Findings in COVID-19 and Influenza H1N1

April 29, 2021 updated by: Jaime Daniel Mondragón Uribe, Universidad de Guanajuato

Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients at IMSS Guanajuato

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 evaluate the association between the radiological CT pattern and the need for invasive mechanical ventilation. A secondary aim is to assess the mortality within the first 28 days of intensive care unit admission.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. Few studies 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. Is there a difference among lung CT radiological patterns in patients with pneumonia secondary to SARS-CoV-2 and its association with the need for invasive mechanical ventilation?
  4. Is there a difference among lung CT radiological patterns in patients with pneumonia secondary to H1N1 influenza and its association with the need for invasive mechanical ventilation?
  5. Is there a difference between groups (i.e. SARS-CoV-2 versus H1N1 influenza) and its association with the need for the use of invasive mechanical ventilation?
  6. Are the 28-day survival distributions different for SARS-CoV-2 and H1N1 influenza?
  7. 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?
  8. Is there a difference in the 28-day survival distribution and the pulmonary tomographic radiological patterns in patients with pneumonia secondary to H1N1 influenza?
  9. What factors are associated with the survival differences in 28-day mortality in both groups and between groups?

Aims Primary aim: Compare pulmonary tomographic findings of patients diagnosed with SARS-CoV-2 and H1N1 influenza pneumonia patients at Hospital General Regional Leon IMSS no. 58.

Secondary aims

  • Identify pulmonary CT radiological patterns in patients diagnosed with SARS-CoV-2 pneumonia.
  • Identify pulmonary CT radiological patterns in patients diagnosed with influenza H1N1 pneumonia.
  • Identify the association between CT patterns of patients diagnosed with SARS-CoV-2 or H1N1 influenza pneumonia who require invasive mechanical ventilation.
  • Identify the CT patterns of SARS-CoV-2 and H1N1 influenza patients that are associated with 28-day mortality.

Statistical analysis No literature is available to calculate the primary objective (i.e. measure the frequency of radiological patterns associated with viral pneumonia secondary to SARS-CoV-2 and H1N1 influenza) or for the secondary objective (risk of intubation) this study will serve as a pilot study for the calculation of samples in future research projects. A sample calculation was performed to determine statistically significant differences in the outcome of radiological patterns secondary to H1N1 influenza. The sample size was calculated based on the proportions reported by Jartti et al. (2011). The sample size was calculated to detect statistically significant differences taking as parameters an α = 0.05 and statistical power of 0.8 (i.e. 1-β). The calculator was used to calculate sample sizes based on proportions of two samples considering the equality of the two extremes (i.e. one Gaussian distribution tail), available on the website: http://powerandsamplesize.com/. The parameters are as follows: nA, number of patients with H1N1 influenza in the reference study (i.e. 159); nB, number of patients with H1N1 influenza pneumonia; pA, frequency of patients with radiological consolidation data, in percentage, for previously reported H1N1 influenza patients (i.e. 93%); pB, frequency of patients with radiological consolidation syndrome, in percentage, in patients with H1N1 influenza pneumonia in our population (i.e. H0: probability = 0.5); k, sampling ratio (i.e. 1: 1). Considering the results, we consider that a sample greater than 23 patients with H1N1 influenza pneumonia is necessary to detect differences in radiological patterns in patients with viral pneumonia.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37268
        • Recruiting
        • Hospital General Regional Leon Imss N0. 58
        • Contact:
        • Contact:
          • Bertha I Arevalo-Rivas, MD
          • Phone Number: 52 477 101 5110
          • Email: barevalo@ugto.mx
        • Principal Investigator:
          • Jaime D Mondragon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Convenience sample from a Mexican a primarily urban and suburban population. All patients are affiliated with a health care system that is sponsored by the state, business owners, and the labor force. Patients primarily represent the working class from a country with a high (0.767) Human Development Index.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV-2
Patients with a positive SARS-CoV-2 PCR test upon admission to the emergency department.
Diagnostic test: Lung CT
Computed tomography of the thorax
H1N1 influenza
Patients with a positive Influenza H1N1 PCR test upon admission to the emergency department.
Diagnostic test: Lung CT
Computed tomography of the thorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral intubation
Time Frame: 10 days
Need for oral intubation within the first 10 days.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 28 days
28-day survival analysis using the Kaplan Meyer and Cox regression models.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Collaborators

University Medical Center Groningen

Investigators

  • Principal Investigator: Jaime D Mondragon, M.D., University Medical Center Groningen
  • Principal Investigator: Omar Jiménez-Zarazúa, M.D., Universidad de Guanajuato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-2020-1008-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data availability upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Lung CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe