Clinical trial NCT05384886: Impact of New Variants and Vaccines on the Course of COVID-19
Official title: New Variants and Vaccines; Did it Cause a Change in the Mortality of COVID-19?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
COVID-19 vaccines
SARS-CoV-2 strains
mortality
Case fatality rate
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 15967
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of COVID-19 patients diagnosed daily
timeFrame: 374 day
Secondary outcomes:
measure: Case fatality rate
timeFrame: 374
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: IKCU, Atatürk Eğitim ve Araştırma Hastanesi, Acil Tıp
Study officials:
References: