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Tomographic Findings in COVID-19 and Influenza H1N1

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: NCT04499378
Recruitment Status : Not yet recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
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 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.

Condition or disease Intervention/treatment
Covid19 Influenza A H1N1 Intubation Complication Morality Lung Injury, Acute Diagnostic Test: Lung CT

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients at IMSS Guanajuato
Estimated Study Start Date : August 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 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




Primary Outcome Measures :
  1. Oral intubation [ Time Frame: 10 days ]
    Need for oral intubation within the first 10 days.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 28 days ]
    28-day survival analysis using the Kaplan Meyer and Cox regression models.


Biospecimen Retention:   Samples With DNA
Polymerase chain reaction for SARS-CoV-2 and polymerase chain reaction for influenza H1N1.


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 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.
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): NCT04499378


Contacts
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Contact: Omar Jiménez-Zarazúa, M.D. +52-442-1377672 drzarazuainterna@hotmail.com

Sponsors and Collaborators
Universidad de Guanajuato
University Medical Center Groningen
Investigators
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Principal Investigator: Jaime D Mondragon, M.D. University Medical Center Groningen
Principal Investigator: Omar Jiménez-Zarazúa, M.D. Universidad de Guanajuato
Publications of Results:

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Responsible Party: Jaime Daniel Mondragón Uribe, Medical researcher, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT04499378    
Other Study ID Numbers: F-2020-1008-038
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data availability upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Lung Injury
Acute Lung Injury
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Thoracic Injuries
Wounds and Injuries