Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001265965
Ethics application status
Not required
Date submitted
5/09/2020
Date registered
25/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
25/11/2020
Date results information initially provided
25/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidemiology and clinical features in patients with COVID-19 in Mexican Southeast: A retrospective analysis
Scientific title
Epidemiology and clinical features in patients with COVID-19 in Mexican Southeast: A retrospective analysis
Secondary ID [1] 301931 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
COVID-19 318453 0
Condition category
Condition code
Infection 316461 316461 0 0
Studies of infection and infectious agents
Respiratory 316462 316462 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Coronavirus disease 2019 (COVID-19) caused by the virus SARS-CoV-2 defines as a pandemic respiratory infection that causes fever, cough, dyspnea, and pulmonary interstitial damage. Unfortunately, SARS-CoV-2 is fastly transmittable between humans and has affected approximately 17.6 million people worldwide. As of July 2020, the World Health Organization (WHO) reported around 425000 confirmed cases in Mexico. In Tabasco, a state of the southeast of Mexico has reported 21300 cases for COVID-19.
The "Dr. Juan Graham Casasús" Hospital received nearly 3000 patients during the pick of the pandemic. Therefore, this proposal is based on the outcomes of hospitalized patients by COVID-19 in Tabasco. This retrospective study will evaluate the medical records of patients diagnosed with COVID-19 in a third-level hospital in Tabasco, from admission until discharge/death.
We will collect sociodemographic, comorbidities, and clinical symptoms at admission, then pharmacological treatment, and laboratory data.
Intervention code [1] 318216 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325008 0
Gender and age with high mortality by COVID-19 in "Dr. Juan Graham Casasús" Hospital in Tabasco Mexico.
Timepoint [1] 325008 0
Hospital admission until discharge or death through clinical records.
Primary outcome [2] 325023 0
Routine blood test (complete blood count, coagulation test), in patients hospitalized by COVID-19.
Timepoint [2] 325023 0
Routine blood test were performed at hospital admission (baseline) and will include three timepoints until discharge or death. We obtained complete blood count, coagulation test, and inflammatory markers through clinical records.
Primary outcome [3] 325529 0
Inflammatory markers (PCR, IL-6, Ferritin) in patients hospitalized by COVID-19.
Timepoint [3] 325529 0
Inflammatory markers were performed at hospital admission (baseline) and will include three timepoints until discharge or death. We obtained complete blood count, coagulation test, and inflammatory markers through clinical records.
Secondary outcome [1] 386538 0
Presence hypertension in patients with COVID-19 in "Dr. Juan Graham Casasús" Hospital in Tabasco Mexico.
Timepoint [1] 386538 0
Hospital admission through clinical records.
Secondary outcome [2] 389064 0
Presence of diabetes in patients with COVID-19 in "Dr. Juan Graham Casasús" Hospital in Tabasco Mexico.
Timepoint [2] 389064 0
Hospital admission through clinical records.
Secondary outcome [3] 389065 0
Presence of obesity in patients with COVID-19 in "Dr. Juan Graham Casasús" Hospital in Tabasco Mexico.
Timepoint [3] 389065 0
Hospital admission through clinical records.

Eligibility
Key inclusion criteria
All survivors and non-survivors patients diagnosed with COVID-19 in a third level hospital in Tabasco, Mexico.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients hospitalized by other clinical conditions.
Patients without vital signs at respiratory triage.
Patients hospitalized with incomplete clinical records.
Pregnancy women.
Age <18 years.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
First, all data will be analyzed by the descriptive statistic.
To describe demographic, clinical, and laboratory variables will be used a frequency distribution, central tendency, and dispersion, according to the case.
Second, we will compare all variables in survivor and non-survivor patients. Categorical variables will compare using the x2 test or Fisher’s test., Quantitative variables will be compared using the t-test.
Third, multiple logistic regression will be used to identify predictors of mortality.
All analyses will be processed by SPSS for windows version 21.0.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
30/03/2020
Date of last participant enrolment
Anticipated
Actual
15/09/2020
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment outside Australia
Country [1] 22918 0
Mexico
State/province [1] 22918 0
Tabasco

Funding & Sponsors
Funding source category [1] 306345 0
Hospital
Name [1] 306345 0
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasús"
Country [1] 306345 0
Mexico
Primary sponsor type
Hospital
Name
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasús"
Address
Calle Uno S/N, Miguel Hidalgo III Etapa, 86126 Villahermosa, Tab., México.
Country
Mexico
Secondary sponsor category [1] 306849 0
None
Name [1] 306849 0
Address [1] 306849 0
Country [1] 306849 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
SARS-CoV-2 is fastly transmittable between humans and has affected approximately 17.6 million people worldwide. As of July 2020, the World Health Organization (WHO) reported around 425000 confirmed cases in Mexico.
In Tabasco, a state located in southeast Mexico reported 21300 cases for COVID-19. It is noteworthy that "Dr. Juan Graham Casasús" Hospital is the most important for the COVID-19 attention in Tabasco. Hence, the present study aims to determine the sociodemographic, clinical, imaging features, and biochemical levels of adult survivors and non-survivors of COVID-19 infection treated at the "Dr. Juan Graham Casasus" Hospital in Tabasco, Mexico.
So the retrospective analysis of the epidemiology and clinical features in patients with COVID-19 contributes to the scientific actualization of clinical work carried out during the pandemic.
Trial website
Trial related presentations / publications
Public notes
Ethics approval is not required for this study because this work is categorizing as risk-free in Mexico. Due to this, retrospective nature will be obtained data from the medical records and will be guaranteed the anonymity of the patients.

Contacts
Principal investigator
Name 104270 0
Dr Jesús Arturo Ruiz Quiñones
Address 104270 0
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus".
Calle Uno S/N, Miguel Hidalgo III Etapa, 86126 Villahermosa, Tabasco, México.
Country 104270 0
Mexico
Phone 104270 0
+529933100300
Fax 104270 0
Email 104270 0
[email protected]
Contact person for public queries
Name 104271 0
Dr Jesús Arturo Ruiz Quiñones
Address 104271 0
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus".
Calle Uno S/N, Miguel Hidalgo III Etapa, 86126 Villahermosa, Tabasco, México.
Country 104271 0
Mexico
Phone 104271 0
+529933100300
Fax 104271 0
Email 104271 0
[email protected]
Contact person for scientific queries
Name 104272 0
Dr Guadalupe del Carmen Baeza Flores
Address 104272 0
Hospital Regional de Alta Especialidad "Dr. Juan Graham Casasus".
Calle Uno S/N, Miguel Hidalgo III Etapa, 86126 Villahermosa, Tabasco, México.
Country 104272 0
Mexico
Phone 104272 0
+529933100300
Fax 104272 0
Email 104272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo None

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIClinical and Virological Features of SARS-CoV-2 Variants during the Four Waves of the Pandemic in the Mexican Southeast2023https://doi.org/10.3390/tropicalmed8030134
N.B. These documents automatically identified may not have been verified by the study sponsor.