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Characteristics of COVID-19 Patients in Kazakhstan in Early 2020

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627194
Recruitment Status : Unknown
Verified November 2020 by Semey State Medical University.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Semey State Medical University

Brief Summary:
The aim of this study is to assess the epidemiological and clinical features of patients diagnosed with COVID-19 in Kazakhstan at the onset of the pandemic.

Condition or disease
Covid19 Pneumonia, Viral

Detailed Description:
There is a paucity of data available on the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in Kazakhstan. While a global effort in search for effective treatments and vaccines against COVID-19 is in effect, it is important that high quality and up-to-date information be available from a broad variety of populations on the dynamics of infection. This is especially important in regions where, due to resource shortage, epidemiologic surveillance may have gaps. To address the current gaps, medical records will be obtained for patients with confirmed COVID-19 during the first months of the pandemic (February-April 2020). The epidemiologic and clinical features including the demographics, clinical manifestation, laboratory parameters, radiologic assessments and clinical outcomes will be analyzed. The results of this study will facilitate the clinical management of COVID-19 patients in Kazakhstan and ultimately inform the ongoing efforts to curb the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the region.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiological and Clinical Characteristics of COVID-19 Patients in Kazakhstan in Early 2020: a Retrospective, Observational Cohort Study
Actual Study Start Date : February 20, 2020
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Mild and asymptomatic COVID-19 patients
Symptomatic patients meeting the World Health Organization (WHO) case definition for COVID-19 without evidence of viral pneumonia or hypoxia, who have a laboratory-confirmed SARS-CoV-2 infection, or asymptomatic patients with a laboratory-confirmed SARS-CoV-2 infection at the time of hospitalization.
Moderate severity COVID-19 patients
Symptomatic patients with a laboratory-confirmed SARS-CoV-2 infection, meeting the WHO case definition for moderate COVID-19 disease severity [including clinical signs of pneumonia e.g. fever, cough, dyspnoea, fast breathing, but no signs of severe pneumonia] at the time of hospitalization.
Severe-to-critical COVID-19 patients
Symptomatic patients with a laboratory-confirmed SARS-CoV-2 infection, meeting the WHO case definition(s) for severe COVID-19 disease presentation [including clinical signs of pneumonia e.g. fever, cough, dyspnoea, fast breathing, and one of the following: respiratory rate > 30 breaths/min; severe respiratory distress; or oxygen saturation (SpO2) < 90% on room air] or for critical COVID-19 disease presentation [including acute respiratory distress syndrome (ARDS), sepsis, septic shock or other complications such as acute pulmonary embolism, acute coronary syndrome, acute stroke and delirium] at the time of hospitalization.
COVID-19 survivors
Patients diagnosed with a laboratory-confirmed COVID-19, who survived.
COVID-19 non-survivors
Patients diagnosed with a laboratory-confirmed COVID-19, who did not survive.



Primary Outcome Measures :
  1. Clinical and demographic predictors of disease severity among hospitalized COVID-19 patients. [ Time Frame: approximately 70 days ]
    Risk factors associated with disease severity and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.

  2. Clinical and demographic predictors of mortality among hospitalized COVID-19 patients. [ Time Frame: approximately 70 days ]
    Risk factors associated with death and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.



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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medical records will be obtained for all subjects, who presented with COVID-19-like symptoms or had a suspected exposure to SARS-CoV-2 between Feb 20 and April 30, 2020 as reported to the Republican Centre for Health Development by regional hospitals. Only those patients who had a positive SARS-CoV-2 PCR test result will be included in the analysis of primary and secondary outcome measures.
Criteria

Inclusion Criteria:

  • Laboratory confirmation of SARS-CoV-2 infection by polymerase chain reaction.

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): NCT04627194


Locations
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Kazakhstan
Semey Medical University
Semey, East Kazakhstan, Kazakhstan
Sponsors and Collaborators
Semey State Medical University
Investigators
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Study Chair: Yersin Zhunussov, MD, D.M.S. Semey Medical University
Study Director: Raifa Ivanova, MD, D.M.S. Semey Medical University
Principal Investigator: Maiya Goremykina, M.D, C.M.S Semey Medical University
Principal Investigator: Sergey Yegorov, Ph.D. Nazarbayev University, School of Sciences and Humanities
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Responsible Party: Semey State Medical University
ClinicalTrials.gov Identifier: NCT04627194    
Other Study ID Numbers: 76.29.31_48.04.06-01
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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COVID-19
Pneumonia, Viral
Respiratory Tract Infections
Infections
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases