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

New Variants and Vaccines; Did it Cause a Change in the Mortality of COVID-19?

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Polymerase chain reaction

Detailed Description

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 spread to many countries in a few weeks, becoming a global public health problem, and the World Health Organization declared it a pandemic on March 11, 2020. COVID-19 has caused widespread deaths worldwide, especially by causing widespread involvement in the lungs and Acute Respiratory Distress Syndrome. 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. The CFR for COVID 19 is the number of deaths in COVID-19 cases divided by the total number of people infected with COVID-19. After the emergence of the disease in 2019, the CFR figures reported for COVID-19 in 2020 began to become clear. In the data coming in 2020, COVID-19 CFR values are 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 the vaccine applications developed against COVID-19. The first vaccine studies have matured by 2020 and started to be applied widely in the world in 2021. the second is the new variants of the first emerging SARS-CoV-2. In 2021, variants started to be defined and Alpha, Beta, Delta, and Omicron variants were reported as dominance variants from time to time. 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. Knowing the possible changes that may occur in COVID-19 mortality may cause changes in the COVID-19 measures applied all over the world. In this way, it may be possible to reduce unnecessary health costs and direct health resources to appropriate areas.

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.

In this study, patient data were obtained retrospectively in a training and research hospital COVID-19 outpatient clinic. The obtained daily number of patients in 2020, CFR rates were compared with the number of daily patients and CFR rates in 2022. In this way, it was tested whether there was a significant difference between the year 2020, when the disease first became widespread, and 2022.

• Study Type: Observational
• Enrollment (Actual): 15967

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35360
    • IKCU, Atatürk Eğitim ve Araştırma Hastanesi, Acil Tıp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1: COVID-19 patients in 2020; All patients over the age of 18 diagnosed with COVID-19 in 2020	Diagnostic test: Polymerase chain reaction; Covid-19 genetic material detection from mouth and nose swab
Group: COVID-19 patients in 2022; All patients over the age of 18 diagnosed with COVID-19 in 2022	Diagnostic test: Polymerase chain reaction; Covid-19 genetic material detection from mouth and nose swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Case fatality rate	The ratio of the number of deaths in diagnosed cases to the total number of people infected.	374

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; mortality; Case fatality rate; COVID-19 vaccines; SARS-CoV-2 strains
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB-867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data and statistical analyzes will be shared with academics and official institutions requesting the patient's names, provided that they remain confidential, after the permission of the institution.
• IPD Sharing Time Frame: Starting in January 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No