Impact of New Variants and Vaccines on the Course of COVID-19

NCT05384886 | Completed

• 1 other identifier: IRB-867
• Study Type: observational
• Target: 15,967
• Locations: 1 country
• Sites: 1

Brief Summary

Novel coronavirus disease (COVID-19), caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, was first reported in December 2019 in Wuhan, China. The disease has spread to many countries in a few weeks and has become a global public health problem. By 2022, the virus has infected more than 500 million people worldwide and caused more than 6 million deaths. Case fatality rates (CFR) are an important index that helps to understand the epidemiological characteristics of an epidemic. In the data coming in 2020, COVID-19 CFR values were generally reported in the range of 0.001-0.706. However, from 2019 to 2022, there were 2 major changes that could affect the CFR of the disease. The first of these is vaccine applications, and the second is the new variants of SARS-CoV-2, which appeared first. From 2019 to 2022, it is likely that there will be a change in the mortality of COVID-19 in relation to both the vaccines administered and the new variants emerging. However, the data on this subject are not clear yet and more studies are needed. The aim of this study is to determine whether there is a change in the mortality of COVID-19 from 2019, when it first appeared, to 2022.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; COVID-19 vaccines; SARS-CoV-2 strains; mortality; Case fatality rate

Outcome Measures

Primary Outcomes (1)

• Number of COVID-19 patients diagnosed daily

  Patients who applied to the COVID-19 outpatient clinic and service and whose diagnosis was confirmed by PCR test

  374 day

Secondary Outcomes (1)

• Case fatality rate

  374

Study Arms (2)

Group1: COVID-19 patients in 2020

All patients over the age of 18 diagnosed with COVID-19 in 2020

Diagnostic Test: Polymerase chain reaction

Group: COVID-19 patients in 2022

All patients over the age of 18 diagnosed with COVID-19 in 2022

Diagnostic Test: Polymerase chain reaction

Interventions

Polymerase chain reaction DIAGNOSTIC_TEST

Covid-19 genetic material detection from mouth and nose swab

Group1: COVID-19 patients in 2020; Group: COVID-19 patients in 2022

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All nontraumatic adult patients of both sexes with positive PCR tests and admitted with suspected symptoms of COVID-19 were included in the study.

You may qualify if:

• \- All patients with a confirmed diagnosis of COVID-19 by PCR testing

You may not qualify if:

• Under 18 years old
• Clinical outcome cannot be followed
• Patients with severe trauma

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

IKCU, Atatürk Eğitim ve Araştırma Hastanesi, Acil Tıp

Izmir, 35360, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 20, 2022
• Study Start: January 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 19, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting in January 2024

Locations

TU (1)