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OpenTrials
Completed

NCT Number: NCT05384886

Impact of New Variants and Vaccines on the Course 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.

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Key information

Study type

Observational

Primary location

IKCU, Atatürk Eğitim ve Araştırma Hastanesi, Acil Tıp

Izmir, 35360, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymerase chain reaction

Diagnostic Test

Covid-19 genetic material detection from mouth and nose swab

Primary outcomes

  1. Number of COVID-19 patients diagnosed daily

    Time frame: 374 day

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

Secondary outcomes

  1. Case fatality rate

    Time frame: 374

    The ratio of the number of deaths in diagnosed cases to the total number of people infected.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 20, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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