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Completed

NCT Number: NCT04912700

The Impact of Vaccination on Severity of Illness in COVID-19

With the FDA's emergency use authorization declaration in December of 2020, the Pfizer-BioNtech vaccine became the first of several vaccines to kick off the mass vaccination effort across the United States against CoronaVIrus Disease 2019 (COVID-19). Subsequently, Moderna as well as Johnson and Johnson both had vaccines receive emergency use authorization. While the Pfizer and the Moderna vaccines both utilize novel mRNA technology, Johnson and Johnson's vaccine uses a viral vector that has been used previously in both the approved European Ebola vaccine and a trial vaccine for HIV. However, none of these vaccine types have previously been approved in the United States. While preliminary data from safety and efficacy trials have shown positive results, actual-world data on its effectiveness is still lacking. Several small cohort studies and one large trial from Israel are currently the only insights into the actual rates of infection, hospitalization, and severe illness among vaccinated individuals. As COVID-19 variants, with the potential to reduce vaccine efficacy, continue to emerge worldwide, there is a need of more data regarding the real-world effectiveness of our current mass vaccination efforts.

Vaccination efforts in the State of Michigan have been ongoing since December 2020. Given that approximately 33.7% of the state's population is either partially or fully vaccinated, it is unclear why the number of cases has risen so dramatically or if immunization efforts can help the situation.

Given the current situation in the State of Michigan, this study will evaluate the efficacy of COVID-19 vaccination on rates of hospital visits and severe illness when breakthrough Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2) infection occurs in a region with high incidence of variant strain disease.

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Key information

Conditions

Covid19 Breakthrough Infections COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

About this study

A retrospective chart review of all patients presenting to Beaumont Health System emergency departments between December 15, 2020 and April 30, 2021 who tested positive for COVID-19 will be performed. The primary aim is to compare the rate of Emergency Department (ED) presentations/hospitalizations among unvaccinated, partially vaccinated, and fully vaccinated patients presenting to an emergency center (EC). Secondarily, the rates of individual clinical outcomes of COVID-19 infection for hospitalized patients will be compared among unvaccinated, partially vaccinated, and fully vaccinated patients, including the proportion of COVID-positive patients who develop severe disease, require admission to the hospital, and rates of those requiring intensive care unit (ICU) admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT), supplemental oxygenation, or noninvasive ventilation, as well as the rate of in-hospital mortality and the hospital length of stay. Exploratory outcomes may include comparisons among fully-vaccinated individuals receiving each of the three types of vaccines, and investigation of demographic, epidemiological, clinical and laboratory predictors of hospitalization. For each individual, data collected will include vital signs (temperature, blood pressure, heart rate, respiratory rate, pulse oximetry), demographics (age, gender, existing medical conditions), home medications, chief complaint from emergency provider note, duration of symptoms in days at the time of presentation from emergency provider note, chest X-ray or chest computed tomography (CT) results, and laboratory values. For patients who were admitted, data collected will include initial hospital admission unit (regular medical or surgical floor, progressive floor, intensive care unit), change in unit type during admission, oxygen therapy (none, nasal cannula, supplemental high flow oxygen, ventilator), days on high flow oxygen, days on ventilator, specific inpatient medical therapies, laboratory values, imaging results, hospital length of stay, and disposition from hospital (home, rehabilitation unit, death).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients presenting to Beaumont Health emergency departments who have tested positive for COVID-19 between December 15, 2020 and April 30, 2021 with available vaccination data through state of Michigan registry.

Exclusion criteria

  • Patients who have previously tested positive for COVID-19 prior to the study period will be excluded.
  • Patients with missing vaccine status will be excluded.

Treatment and study plan

COVID-19 vaccine

Biological

Full or partial reception of vaccine

Other names: Pfizer vaccine, Moderna vaccine, Johnson & Johnson vaccine

Primary outcomes

  1. Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test

    Time frame: During the period from December 15, 2020 through April 30, 2021 (up to 5 months)

    Number of participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test

Secondary outcomes

  1. Number of Patients With Severe Infection

    Time frame: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality

  2. Number of Patients With ICU Admission

    Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)

    Number of patients admitted to ICU during hospital stay

  3. Number of Patients Requiring Mechanical Ventilation

    Time frame: During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Number of patients who required mechanical ventilation

  4. Number of Patients With In-hospital Mortality

    Time frame: During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Number of patients who died during EC visit or hospital admission

  5. Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)

    Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)

    Number of hospitalized patients requiring ECMO

  6. Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT)

    Time frame: During hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Number of hospitalized patients requiring RRT

  7. Number of Hospitalized Patients Requiring Supplemental Oxygen

    Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)

    Number of hospitalized patients requiring supplemental oxygen, by type

  8. Number of Hospitalized Patients Requiring Non-invasive Ventilation

    Time frame: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Number of hospitalized patients requiring non-invasive ventilation

  9. Number of Hospitalized Patients Requiring Vasopressors

    Time frame: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)

    Number of hospitalized patients with hypotension requiring vasopressors

  10. Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.

    Time frame: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)

    Number of patients discharged from in-patient hospital admission to home, skilled nursing facility, rehabilitation facility, or hospice.

  11. Hospital Length of Stay

    Time frame: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)

    Number of days from admission after emergency center (EC) visit and positive COVID-19 test, until discharge

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Official study title

The Impact of Vaccination on Severity of Illness in COVID-19: A Multicenter Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Sep 30, 2021

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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