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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

Tracking Information
First Submitted Date November 6, 2020
First Posted Date November 13, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date February 20, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characteristics of COVID-19 Patients in Kazakhstan in Early 2020
Official Title Epidemiological and Clinical Characteristics of COVID-19 Patients in Kazakhstan in Early 2020: a Retrospective, Observational Cohort Study
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Covid19
  • Pneumonia, Viral
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 12, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Laboratory confirmation of SARS-CoV-2 infection by polymerase chain reaction.
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04627194
Other Study ID Numbers 76.29.31_48.04.06-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Semey State Medical University
Original Responsible Party Same as current
Current Study Sponsor Semey State Medical University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
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
PRS Account Semey State Medical University
Verification Date November 2020