Covid19NCT04912700
The Impact of Vaccination on Severity of Illness in COVID-19
An observational study of Covid19, run by Corewell Health East at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 11,834 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 7 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients during study period with COVID-19 infection and EC visit.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: The Impact of Vaccination on Severity of Illness in COVID-19: A Multicenter Cohort Study
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.
Read the detailed 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).
- Conditions
- Covid19
- Being tested
- COVID-19 vaccine
- Keywords
- vaccination, efficacy, severe outcomes, mortality, variants, breakthrough infection, COVID-19, SARS-Cov-2 virus
- Medical subject headings
- COVID-19, Breakthrough Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
Also called Pfizer vaccine, Moderna vaccine, Johnson & Johnson vaccine
Full or partial reception of vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the period from December 15, 2020 through April 30, 2021 (up to 5 months)
Secondary outcomes (11)
Number of Patients With Severe Infection
Patient with any of the following: ICU admission, mechanical ventilation, or in-hospital mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jun 2021
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Bahl, Corewell Health East
- Investigators
- Amit Bahl, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912700
- Sponsor's protocol ID
- 2021-118
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2021
- Last updated
- 30 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this point.
Publications
Azar AM. Emergency Use Authorization Declaration. Published online 2020. https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration
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
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.
PubMed 32227757Emary 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.
PubMed 33798499Dagan 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.
PubMed 33626250Daniel 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.
PubMed 33755374Amit 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.
PubMed 33610193Sanders 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.
PubMed 33798497State of Michigan COVID-19 Vaccine Dashboard. https://www.michigan.gov/coronavirus/0,9753,7-406-98178_103214-547150--,00.html. Retrieved 25 April 2021.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vaccination on Severity of Illness in COVID-19: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04912700
- Acronym / sponsor ID
- 2021-118
- Conditions
- Covid19
- Keywords
- vaccination, efficacy, severe outcomes, mortality, variants, breakthrough infection, COVID-19, SARS-Cov-2 virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,834 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 30 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Biological: COVID-19 vaccinePartially 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 | – | Biological: COVID-19 vaccineFully 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients during study period with COVID-19 infection and EC visit.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineAlso: Pfizer vaccine, Moderna vaccine, Johnson & Johnson vaccineFull or partial reception of vaccine | Biological | Fully vaccinated, Partially vaccinated |
Primary outcome
Number of Participants With Emergency Center (EC) Encounters 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 participants with encounters at emergency center (EC) and /or hospitalizations with positive COVID-19 test
11 secondary outcomes
Number of Patients With Severe Infection
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
Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)
Number of Patients Requiring 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
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)
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)
Time frame: During hospitalization, from date of presentation until May 15, 2021 (up to 5 months)
Number of Hospitalized Patients Requiring Supplemental Oxygen
Time frame: During hospitalization, from date of admission until May 15, 2021 (up to 5 months)
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
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.
Time frame: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)
Hospital Length of Stay
Time frame: During the period from December 15, 2020 through May 15, 2021 (up to 5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAzar AM. Emergency Use Authorization Declaration. Published online 2020. https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration
- BackgroundUS 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: PubMed 32227757Lurie 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.
- Background: PubMed 33798499Emary 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.
- Background: PubMed 33626250Dagan 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.
- Background: PubMed 33755374Daniel 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.
- Background: PubMed 33610193Amit 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.
- Background: PubMed 33798497Sanders 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.
- BackgroundState of Michigan COVID-19 Vaccine Dashboard. https://www.michigan.gov/coronavirus/0,9753,7-406-98178_103214-547150--,00.html. Retrieved 25 April 2021.
- Individual participant dataSharing planned: No. No plan at this point.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Bahl principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Emergency Center (EC) Encounters 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912700, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.