An observational study in Covid19, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by William Beaumont Hospitals · Observational
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.
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 11,834 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consecutive patients during study period with COVID-19 infection and EC visit.
Exclusion Criteria:
Unvaccinated individuals are defined as having positive laboratory COVID-19 testing with no record of immunization against COVID-19 or first-dose vaccination after symptom onset.
Partially vaccinated individuals are defined as having positive laboratory COVID-19 testing and symptom onset after a single dose of either mRNA (Pfizer, Moderna) vaccine, or \< 14 days after the second dose of either mRNA vaccine (Pfizer, Moderna) or \< 14 days after the administration of the single dose of viral vector vaccine (Johnson \& Johnson).
Biological: COVID-19 vaccine
Fully vaccinated individuals are defined as having positive laboratory testing for COVID-19 and symptom onset \>14 days since administration of second dose of either mRNA vaccine, or \>14 days since administration of viral vector vaccine (Johnson \& Johnson).
Biological: COVID-19 vaccine
Full or partial reception of vaccine
Also known as: Pfizer vaccine, Moderna vaccine, Johnson & Johnson vaccine
Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test
Number of participants with encounters at emergency center (EC) 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 Patients With Severe Infection
Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality
Time frame: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
Number of Patients With ICU Admission
Number of patients admitted to ICU during hospital stay
Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)
Number of Patients Requiring Mechanical Ventilation
Number of patients who required 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 With In-hospital Mortality
Number of patients who died during EC visit or hospital admission
Time frame: During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)
Number of hospitalized patients requiring ECMO
Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)
Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT)
Number of hospitalized patients requiring RRT
Time frame: During hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
Number of Hospitalized Patients Requiring Supplemental Oxygen
Number of hospitalized patients requiring supplemental oxygen, by type
Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)
Number of Hospitalized Patients Requiring Non-invasive Ventilation
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 Vasopressors
Number of hospitalized patients with hypotension requiring vasopressors
Time frame: During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice.
Number of patients discharged from in-patient hospital admission 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)
Hospital Length of Stay
Number of days from admission after emergency center (EC) visit and positive COVID-19 test, until discharge
Time frame: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)
| Milestone | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Started | 10880 | 825 | 129 |
| Completed | 10880 | 825 | 129 |
| Not completed | 0 | 0 | 0 |
Number of participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test | 10880 | 825 | 129 |
Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Patients With Severe Infection | 733 | 85 | 16 |
Number of patients admitted to ICU during hospital stay
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Patients With ICU Admission | 619 | 75 | 14 |
Number of patients who required mechanical ventilation
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Patients Requiring Mechanical Ventilation | 398 | 42 | 6 |
Number of patients who died during EC visit or hospital admission
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Patients With In-hospital Mortality | 384 | 50 | 8 |
Number of hospitalized patients requiring ECMO
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO) | 4 | 0 | 0 |
Number of hospitalized patients requiring RRT
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT) | 130 | 14 | 0 |
Number of hospitalized patients requiring supplemental oxygen, by type
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Nasal canula | 2563 | 231 | 38 |
| High flow oxygen | 656 | 67 | 10 |
| Non-invasive ventilation | 428 | 56 | 10 |
| Mechanical ventilation | 395 | 42 | 6 |
| none | 1208 | 119 | 31 |
Number of hospitalized patients requiring non-invasive ventilation
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Hospitalized Patients Requiring Non-invasive Ventilation | 428 | 56 | 10 |
Number of hospitalized patients with hypotension requiring vasopressors
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Number of Hospitalized Patients Requiring Vasopressors | 348 | 45 | 6 |
Number of patients discharged from in-patient hospital admission to home, skilled nursing facility, rehabilitation facility, or hospice.
| Participants | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Home | 4110 | 368 | 61 |
| Rehabilitation Institute | 72 | 7 | 0 |
| Skilled Nursing Home | 514 | 66 | 20 |
| Hospice | 125 | 21 | 6 |
| Transferred to another facility | 50 | 4 | 0 |
| Death | 379 | 49 | 8 |
Number of days from admission after emergency center (EC) visit and positive COVID-19 test, until discharge
| days | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Hospital Length of Stay | 7.2 ± 7.0 | 7.3 ± 6.3 | 7.0 ± 5.2 |
Collected over December 15, 2020 through May 15, 2021 (up to 5 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unvaccinated | 384/10,880 (3.5%) | 4,176/10,880 (38.4%) | 0/10,880 (0%) |
| Partially Vaccinated | 50/825 (6.1%) | 410/825 (49.7%) | 0/825 (0%) |
| Fully Vaccinated | 8/129 (6.2%) | 64/129 (49.6%) | 0/129 (0%) |
| Event | Unvaccinated | Partially Vaccinated | Fully Vaccinated |
|---|---|---|---|
| Respiratory insufficiencyRespiratory, thoracic and mediastinal disorders | 4046/10880 | 396/825 | 64/129 |
| HypotensionCardiac disorders | 348/10880 | 45/825 | 6/129 |
| Acute renal failureRenal and urinary disorders | 130/10880 | 14/825 | 0/129 |
| Age, Continuous(years) | Unvaccinated | Partially Vaccinated | Fully Vaccinated | Total |
|---|---|---|---|---|
| Mean | 52.1 ± 18.2 | 62.5 ± 15.3 | 70.3 ± 16.4 | 53.0 ± 18.2 |
| Sex: Female, Male(Participants) | Unvaccinated | Partially Vaccinated | Fully Vaccinated | Total |
|---|---|---|---|---|
| Female | 5750 | 425 | 69 | 6244 |
| Male | 5130 | 400 | 60 | 5590 |
| Race (NIH/OMB)(Participants) | Unvaccinated | Partially Vaccinated | Fully Vaccinated | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3452 | 198 | 13 | 3663 |
| White | 6467 | 559 | 108 | 7134 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 961 | 68 | 8 | 1037 |
| Region of Enrollment(participants) | Unvaccinated | Partially Vaccinated | Fully Vaccinated | Total |
|---|---|---|---|---|
| United States | 10880 | 825 | 129 | 11834 |
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Plan to share: No — No plan at this point.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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William Beaumont Hospitals