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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unvaccinated | 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 | 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). |
| |
| Fully vaccinated | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine | Biological | Full or partial reception of vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During the period from December 15, 2020 through April 30, 2021 (up to 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Severe Infection | Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality | During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
| Number of Patients With ICU Admission |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients during study period with COVID-19 infection and EC visit.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Bahl | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Azar AM. Emergency Use Authorization Declaration. Published online 2020. https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration | ||
| Background | US Food and Drug Administration. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. Accessed April 10, 2021. https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine | ||
| 32227757 | Background | Lurie N, Saville M, Hatchett R, Halton J. Developing Covid-19 Vaccines at Pandemic Speed. N Engl J Med. 2020 May 21;382(21):1969-1973. doi: 10.1056/NEJMp2005630. Epub 2020 Mar 30. No abstract available. | |
| 33798499 |
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No plan at this point.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unvaccinated | 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. |
| FG001 | Partially Vaccinated | 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). |
| FG002 | Fully Vaccinated | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unvaccinated | 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. |
| BG001 | Partially Vaccinated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Study population is defined as numbers of participants presenting to EC or hospitalized. | Posted | Count of Participants | Participants | During the period from December 15, 2020 through April 30, 2021 (up to 5 months) |
|
December 15, 2020 through May 15, 2021 (up to 5 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unvaccinated | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Requiring supplemental oxygen, mechanical ventilation or ECMO |
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Retrospective study of medical records
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmit Bahl, MD | Beaumont Hospitals | (248) 898-9111 | ahmit.bahl@beaumont.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2021 | Sep 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2021 | Sep 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000093742 | Breakthrough Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Number of patients admitted to ICU during hospital stay |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | During the period from December 15, 2020 through May 15, 2021 (up to 5 months) |
| Background |
| Emary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, Blane B, Bonsall D, Cicconi P, Charlton S, Clutterbuck EA, Collins AM, Cox T, Darton TC, Dold C, Douglas AD, Duncan CJA, Ewer KJ, Flaxman AL, Faust SN, Ferreira DM, Feng S, Finn A, Folegatti PM, Fuskova M, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hallis B, Heath PT, Hay J, Hill HC, Jenkin D, Kerridge S, Lazarus R, Libri V, Lillie PJ, Ludden C, Marchevsky NG, Minassian AM, McGregor AC, Mujadidi YF, Phillips DJ, Plested E, Pollock KM, Robinson H, Smith A, Song R, Snape MD, Sutherland RK, Thomson EC, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Williams CJ, Hill AVS, Lambe T, Gilbert SC, Voysey M, Ramasamy MN, Pollard AJ; COVID-19 Genomics UK consortium; AMPHEUS Project; Oxford COVID-19 Vaccine Trial Group. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021 Apr 10;397(10282):1351-1362. doi: 10.1016/S0140-6736(21)00628-0. Epub 2021 Mar 30. |
| 33626250 | Background | Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernan MA, Lipsitch M, Reis B, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24. |
| 33755374 | Background | Daniel W, Nivet M, Warner J, Podolsky DK. Early Evidence of the Effect of SARS-CoV-2 Vaccine at One Medical Center. N Engl J Med. 2021 May 20;384(20):1962-1963. doi: 10.1056/NEJMc2102153. Epub 2021 Mar 23. No abstract available. |
| 33610193 | Background | Amit S, Regev-Yochay G, Afek A, Kreiss Y, Leshem E. Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients. Lancet. 2021 Mar 6;397(10277):875-877. doi: 10.1016/S0140-6736(21)00448-7. Epub 2021 Feb 18. No abstract available. |
| 33798497 | Background | Sanders RW, de Jong MD. Pandemic moves and countermoves: vaccines and viral variants. Lancet. 2021 Apr 10;397(10282):1326-1327. doi: 10.1016/S0140-6736(21)00730-3. Epub 2021 Mar 30. No abstract available. |
| Background | State of Michigan COVID-19 Vaccine Dashboard. https://www.michigan.gov/coronavirus/0,9753,7-406-98178_103214-547150--,00.html. Retrieved 25 April 2021. |
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).
COVID-19 vaccine: Full or partial reception of vaccine
| BG002 | Fully Vaccinated | 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). COVID-19 vaccine: Full or partial reception of vaccine |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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). |
| OG002 | Fully Vaccinated | 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). |
|
|
| Secondary | Number of Patients With Severe Infection | Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality | Analysis performed on all patients presenting to EC including those hospitalized | Posted | Count of Participants | Participants | During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Patients With ICU Admission | Number of patients admitted to ICU during hospital stay | Analysis performed on all patients presenting to EC including those hospitalized | Posted | Count of Participants | Participants | During hospitalization, from date of admission until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Patients Requiring Mechanical Ventilation | Number of patients who required mechanical ventilation | Analysis performed on all patients presenting to EC including those hospitalized | Posted | Count of Participants | Participants | During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Patients With In-hospital Mortality | Number of patients who died during EC visit or hospital admission | Analysis performed on all patients presenting to EC including those hospitalized | Posted | Count of Participants | Participants | During EC visit or in-patient hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO) | Number of hospitalized patients requiring ECMO | Analysis performed only on patients hospitalized | Posted | Count of Participants | Participants | During hospitalization, from date of admission until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT) | Number of hospitalized patients requiring RRT | Analysis performed only on patients hospitalized | Posted | Count of Participants | Participants | During hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Hospitalized Patients Requiring Supplemental Oxygen | Number of hospitalized patients requiring supplemental oxygen, by type | Analysis performed only on patients hospitalized | Posted | Count of Participants | Participants | During hospitalization, from date of admission until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Hospitalized Patients Requiring Non-invasive Ventilation | Number of hospitalized patients requiring non-invasive ventilation | Analysis performed only on patients hospitalized | Posted | Count of Participants | Participants | During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
|
|
| Secondary | Number of Hospitalized Patients Requiring Vasopressors | Number of hospitalized patients with hypotension requiring vasopressors | Analysis performed only on patients hospitalized | Posted | Count of Participants | Participants | During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months) |
|
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| Secondary | 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. | Analysis performed only on patients who were admitted to hospital | Posted | Count of Participants | Participants | During the period from December 15, 2020 through May 15, 2021 (up to 5 months) |
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| Secondary | Hospital Length of Stay | Number of days from admission after emergency center (EC) visit and positive COVID-19 test, until discharge | Analysis performed only on patients admitted to hospital after EC visit | Posted | Mean | Standard Deviation | days | During the period from December 15, 2020 through May 15, 2021 (up to 5 months) |
|
|
|
| 384 |
| 10,880 |
| 4,176 |
| 10,880 |
| 0 |
| 10,880 |
| EG001 | Partially Vaccinated | 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). COVID-19 vaccine: Full or partial reception of vaccine | 50 | 825 | 410 | 825 | 0 | 825 |
| EG002 | Fully Vaccinated | 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). COVID-19 vaccine: Full or partial reception of vaccine | 8 | 129 | 64 | 129 | 0 | 129 |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment | Requiring renal replacement therapy |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Requiring vasopressor therapy |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Non-invasive ventilation |
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| Mechanical ventilation |
|
| none |
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| Skilled Nursing Home |
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| Hospice |
|
| Transferred to another facility |
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| Death |
|