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

NCT04912700 | Completed Results

• 1 other identifier: 2021-118
• Study Type: observational
• Target: 11,834
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

vaccination; efficacy; severe outcomes; mortality; variants; breakthrough infection; COVID-19; SARS-Cov-2 virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of Patients With Severe Infection

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

• Number of Patients With ICU Admission

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

• Number of Patients Requiring 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

  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)

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

Study Arms (3)

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).

Biological: COVID-19 vaccine

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).

Biological: COVID-19 vaccine

Interventions

COVID-19 vaccine BIOLOGICAL

Full or partial reception of vaccine

Also known as: Pfizer vaccine, Moderna vaccine, Johnson & Johnson vaccine

Fully vaccinated; Partially vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients during study period with COVID-19 infection and EC visit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Related Publications (9)

• 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

  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.

  PMID: 32227757 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.

  PMID: 33798499 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.

  PMID: 33626250 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.

  PMID: 33755374 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.

  PMID: 33610193 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.

  PMID: 33798497 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.

  BACKGROUND

MeSH Terms

Conditions

COVID-19; Breakthrough Infections

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Retrospective study of medical records

Results Point of Contact

• Title: Ahmit Bahl, MD
• Organization: Beaumont Hospitals

ahmit.bahl@beaumont.edu

(248) 898-9111

Study Officials

• Amit Bahl

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency Ultrasound

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 3, 2021
• Study Start: June 1, 2021
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)