Characteristics of COVID-19 Patients in Kazakhstan in Early 2020

NCT04627194 | Unknown

• 1 other identifier: 76.29.31_48.04.06-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Pneumonia, Viral

Outcome Measures

Primary Outcomes (2)

• Clinical and demographic predictors of disease severity among hospitalized COVID-19 patients.

  Risk factors associated with disease severity and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.

  approximately 70 days

• Clinical and demographic predictors of mortality among hospitalized COVID-19 patients.

  Risk factors associated with death and their odds ratios (ORs) will be assessed by the univariable and multivariable logistic regression models.

  approximately 70 days

Study Arms (5)

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.

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Semey State Medical University: lead

Study Sites (1)

Semey Medical University

Semey, East Kazakhstan, Kazakhstan

Location

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yersin Zhunussov, MD, D.M.S.

  Semey State Medical University

  STUDY CHAIR

• Raifa Ivanova, MD, D.M.S.

  Semey State Medical University

  STUDY DIRECTOR

• Maiya Goremykina, M.D, C.M.S

  Semey State Medical University

  PRINCIPAL INVESTIGATOR

• Sergey Yegorov, Ph.D.

  Nazarbayev University, School of Sciences and Humanities

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: February 20, 2020
• Primary Completion: April 30, 2020
• Study Completion: December 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)