N/A
N=11,834
The Impact of Vaccination on Severity of Illness in COVID-19
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04912700 ↗Enrolled (actual)
11,834
Serious AEs
39.3%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test — 10880; 825; 129 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- COVID-19 vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Emergency Center (EC) Encounters and/or Hospitalizations With Positive COVID-19 Test |
10880; 825; 129 | — |
| SECONDARY Number of Patients With Severe Infection |
733; 85; 16 | — |
| SECONDARY Number of Patients With ICU Admission |
619; 75; 14 | — |
| SECONDARY Number of Patients Requiring Mechanical Ventilation |
398; 42; 6 | — |
| SECONDARY Number of Patients With In-hospital Mortality |
384; 50; 8 | — |
| SECONDARY Number of Hospitalized Patients Requiring Extracorporeal Membrane Oxygenation (ECMO) |
4; 0; 0 | — |
| SECONDARY Number of Hospitalized Patients Requiring Renal Replacement Therapy (RRT) |
130; 14; 0 | — |
| SECONDARY Number of Hospitalized Patients Requiring Supplemental Oxygen |
2563; 231; 38; 656; 67; 10 | — |
| SECONDARY Number of Hospitalized Patients Requiring Non-invasive Ventilation |
428; 56; 10 | — |
| SECONDARY Number of Hospitalized Patients Requiring Vasopressors |
348; 45; 6 | — |
| SECONDARY Number of Patients Discharged From Hospital to Home, Skilled Nursing Facility, Rehabilitation Facility, or Hospice. |
4110; 368; 61; 72; 7; 0 | — |
| SECONDARY Hospital Length of Stay |
7.2; 7.3; 7.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04912700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.