NCT04497311

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

July 31, 2020

Last Update Submit

August 4, 2020

Conditions

SARS-CoV-2Covid19H1N1 InfluenzaComputed Tomography

Keywords

Radiological patterns28-day survival

Outcome Measures

Primary Outcomes (1)

  • Radiological findings

    Lung CT radiological patterns associated with COVID-19 or Influenza H1N1

    24 hours

Secondary Outcomes (1)

  • Survival

    28 days

Study Arms (2)

SARS-CoV-2

Patients with a SARS-CoV-2 polymerase chain reaction positive test upon admission to the emergency department.

Diagnostic Test: Thoraxic computed tomography

H1N1 influenza

Patients with an influenza H1N1 polymerase chain reaction positive test upon admission to the emergency department.

Diagnostic Test: Thoraxic computed tomography

Interventions

Thoraxic computed tomographyDIAGNOSTIC_TEST

Diagnostic lung CT.

H1N1 influenzaSARS-CoV-2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample from a Mexican urban, suburban, and rural population. The patients come from all demographical and socio-economic strata from a country with a high (0.767) Human Development Index. Our hospital is open to the entire population and primarily assists people with limited to very limited resources.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General León-Milenio

León, Guanajuato, 37672, Mexico

RECRUITING

Related Publications (13)

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PMID: 32031570RESULT

  • Dandachi D, Rodriguez-Barradas MC. Viral pneumonia: etiologies and treatment. J Investig Med. 2018 Aug;66(6):957-965. doi: 10.1136/jim-2018-000712. Epub 2018 Apr 20.

    PMID: 29680828RESULT

  • Fineberg HV. Pandemic preparedness and response--lessons from the H1N1 influenza of 2009. N Engl J Med. 2014 Apr 3;370(14):1335-42. doi: 10.1056/NEJMra1208802. No abstract available.

    PMID: 24693893RESULT

  • Louie JK, Acosta M, Winter K, Jean C, Gavali S, Schechter R, Vugia D, Harriman K, Matyas B, Glaser CA, Samuel MC, Rosenberg J, Talarico J, Hatch D; California Pandemic (H1N1) Working Group. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA. 2009 Nov 4;302(17):1896-902. doi: 10.1001/jama.2009.1583.

    PMID: 19887665RESULT

  • Uyeki TM, Bernstein HH, Bradley JS, Englund JA, File TM, Fry AM, Gravenstein S, Hayden FG, Harper SA, Hirshon JM, Ison MG, Johnston BL, Knight SL, McGeer A, Riley LE, Wolfe CR, Alexander PE, Pavia AT. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa. Clin Infect Dis. 2019 Mar 5;68(6):e1-e47. doi: 10.1093/cid/ciy866.

    PMID: 30566567RESULT

  • Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.

    PMID: 21435708RESULT

  • Koo HJ, Lim S, Choe J, Choi SH, Sung H, Do KH. Radiographic and CT Features of Viral Pneumonia. Radiographics. 2018 May-Jun;38(3):719-739. doi: 10.1148/rg.2018170048.

    PMID: 29757717RESULT

  • Shiley KT, Van Deerlin VM, Miller WT Jr. Chest CT features of community-acquired respiratory viral infections in adult inpatients with lower respiratory tract infections. J Thorac Imaging. 2010 Feb;25(1):68-75. doi: 10.1097/RTI.0b013e3181b0ba8b.

    PMID: 20160606RESULT

  • Upchurch CP, Grijalva CG, Wunderink RG, Williams DJ, Waterer GW, Anderson EJ, Zhu Y, Hart EM, Carroll F, Bramley AM, Jain S, Edwards KM, Self WH. Community-Acquired Pneumonia Visualized on CT Scans but Not Chest Radiographs: Pathogens, Severity, and Clinical Outcomes. Chest. 2018 Mar;153(3):601-610. doi: 10.1016/j.chest.2017.07.035. Epub 2017 Aug 9.

    PMID: 28802696RESULT

  • Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.

    PMID: 32083985RESULT

  • Bai HX, Hsieh B, Xiong Z, Halsey K, Choi JW, Tran TML, Pan I, Shi LB, Wang DC, Mei J, Jiang XL, Zeng QH, Egglin TK, Hu PF, Agarwal S, Xie FF, Li S, Healey T, Atalay MK, Liao WH. Performance of Radiologists in Differentiating COVID-19 from Non-COVID-19 Viral Pneumonia at Chest CT. Radiology. 2020 Aug;296(2):E46-E54. doi: 10.1148/radiol.2020200823. Epub 2020 Mar 10.

    PMID: 32155105RESULT

  • Liu M, Zeng W, Wen Y, Zheng Y, Lv F, Xiao K. COVID-19 pneumonia: CT findings of 122 patients and differentiation from influenza pneumonia. Eur Radiol. 2020 Oct;30(10):5463-5469. doi: 10.1007/s00330-020-06928-0. Epub 2020 May 12.

    PMID: 32399710RESULT

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PMID: 32109013RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal (NP) specimen, oropharyngeal (OP) specimen, nasal mid-turbinate swab, anterior nares (nasal swab) specimen, nasopharyngeal wash/aspirate or nasal wash/aspirate (NW) specimen or sputum from upper airways.

MeSH Terms

Conditions

COVID-19Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Omar Jiménez-Zarazúa, M.D.

    Medical researcher, Internist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lourdes N Vélez-Ramírez, M.D.

CONTACT

+52 477 719 7400nestlynoemi@gmail.com

Omar Jiménez-Zarazúa, M.D.

CONTACT

+52 4421377672drzarazuainterna@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical researcher

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

June 15, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2022

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

ME(1)