Tomographic Findings in COVID-19 and Influenza H1N1
Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients at IMSS Guanajuato
1 other identifier
observational
200
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
1 active site
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
First Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedStudy Start
First participant enrolled
August 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMay 3, 2021
April 1, 2021
9 months
August 3, 2020
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Oral intubation
Need for oral intubation within the first 10 days.
10 days
Secondary Outcomes (1)
Survival
28 days
Study Arms (2)
SARS-CoV-2
Patients with a positive SARS-CoV-2 PCR test upon admission to the emergency department.
H1N1 influenza
Patients with a positive Influenza H1N1 PCR test upon admission to the emergency department.
Interventions
Eligibility Criteria
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.
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
- Universidad de Guanajuatolead
- University Medical Center Groningencollaborator
Study Sites (1)
Hospital General Regional Leon Imss N0. 58
León, Guanajuato, 37268, Mexico
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: 32031570RESULTDandachi 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: 29680828RESULTFineberg 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: 24693893RESULTLouie 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: 19887665RESULTUyeki 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: 30566567RESULTRuuskanen 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: 21435708RESULTKoo 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: 29757717RESULTShiley 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: 20160606RESULTUpchurch 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: 28802696RESULTZu 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: 32083985RESULTBai 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: 32155105RESULTLiu 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: 32399710RESULTGuan 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
Polymerase chain reaction for SARS-CoV-2 and polymerase chain reaction for influenza H1N1.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime D Mondragon, M.D.
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
Omar Jiménez-Zarazúa, M.D.
Universidad de Guanajuato
Central Study Contacts
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
August 3, 2020
First Posted
August 5, 2020
Study Start
August 15, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2022
Last Updated
May 3, 2021
Record last verified: 2021-04