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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912700
• Other study ID #: 2021-118
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: June 7, 2021

Study information

• Verified date: September 2021
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11834
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• COVID-19 vaccine
Full or partial reception of vaccine

Locations

Country	Name	City	State
United States	Beaumont Hospital - Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Azar AM. Emergency Use Authorization Declaration. Published online 2020. https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration

Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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	During the period from December 15, 2020 through April 30, 2021 (up to 5 months)
Secondary	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)
Secondary	Number of Patients With ICU Admission	Number of patients admitted to ICU during hospital stay	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	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	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	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	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	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	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	During EC visit or hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
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.	During the period from December 15, 2020 through May 15, 2021 (up to 5 months)
Secondary	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)