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Tomographic Findings in COVID-19 and Influenza (TOMOCOVIDMX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497311
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 6, 2020
Sponsor:
Collaborators:
Hospital General Regional de León
University Medical Center Groningen
Information provided by (Responsible Party):
Jaime Daniel Mondragón Uribe, Universidad de Guanajuato

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.

Condition or disease Intervention/treatment
SARS-CoV-2 Covid19 H1N1 Influenza Computed Tomography Diagnostic Test: Thoraxic computed tomography

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
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
Diagnostic lung CT.

H1N1 influenza
Patients with an influenza H1N1 polymerase chain reaction positive test upon admission to the emergency department.
Diagnostic Test: Thoraxic computed tomography
Diagnostic lung CT.




Primary Outcome Measures :
  1. Radiological findings [ Time Frame: 24 hours ]
    Lung CT radiological patterns associated with COVID-19 or Influenza H1N1


Secondary Outcome Measures :
  1. Survival [ Time Frame: 28 days ]
    Intrahospital and overall survival at 28 days from hospital admission.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497311


Contacts
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Contact: Lourdes N Vélez-Ramírez, M.D. +52 477 719 7400 nestlynoemi@gmail.com
Contact: Omar Jiménez-Zarazúa, M.D. +52 4421377672 drzarazuainterna@hotmail.com

Locations
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Mexico
Hospital General León-Milenio Recruiting
León, Guanajuato, Mexico, 37672
Contact: Lourdes N Veléz-Ramírez, M.D.    +52 477 719 7400    nestlynoemi@gmail.com   
Contact: Omar Jiménez-Zarazúa, M.D.    +52 4421377672    drzarazuainterna@hotmail.com   
Sponsors and Collaborators
Universidad de Guanajuato
Hospital General Regional de León
University Medical Center Groningen
Investigators
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Principal Investigator: Omar Jiménez-Zarazúa, M.D. Medical researcher, Internist
Publications of Results:

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Responsible Party: Jaime Daniel Mondragón Uribe, Medical researcher, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT04497311    
Other Study ID Numbers: HGL-ENSE-00743-20
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A database will be generated and available upon request. All patients will de unidentified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaime Daniel Mondragón Uribe, Universidad de Guanajuato:
Radiological patterns
28-day survival
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases