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PReventing Emerging infections through Vaccine EffectiveNess Testing—COVID (Project PREVENT)

About this Study

The primary objective of this project is:
1) To evaluate post-introduction effectiveness of a complete schedule of SARS-CoV-2 vaccine in preventing laboratory-confirmed symptomatic COVID-19 among HCP.
Secondary objectives include:
1) Estimating the post-introduction effectiveness of SARS-CoV-2 vaccines in preventing severe disease among those with laboratory-confirmed symptomatic COVID-19;
2) Identifying differences in vaccine effectiveness by age group and comorbidity categories;
3) Evaluating vaccine effectiveness in various job categories and clinical practice settings;
4) Estimating the comparative effectiveness of different SARS-CoV-2 vaccines or, for vaccines with 2-dose schedules, 1 vs. 2-doses;
5) Comparing health care and COVID-19 testing practices of HCP within specific job groups;
6) Describing quarantine, isolation, repeat testing, and return-to-work practices among vaccinated and unvaccinated HCP tested for COVID-19;
7) Identifying factors associated with the decision to be vaccinated for SARS-CoV-2; and
8) Evaluating provider behavior changes, use of infection mitigation strategies, and decision-making in response to COVID-19 vaccination.

Sponsor Protocol ID:2020V0341
IRB Number:2020V0341
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Closed for Enrollment
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Observational
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Observational/Not Applicable
Eligibility Criteria
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

No

Inclusion Criteria
Any employee or volunteer in a participating hospital who was tested for COVID-19 is eligible for inclusion, regardless of their degree of patient exposure or vaccination status. HCP will include all paid and unpaid persons in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including:
• Body substances;
• Contaminated medical supplies, devices, and equipment;
• Contaminated environmental surfaces; or
• Contaminated air.

All employees retained for full data collection will meet either Criteria 1 or Criteria 2 during a period from 14 days prior to their first COVID-19 test to 14 days after that test. Asymptomatic participants will be screened for symptom development, and only those who develop Criteria 1 or 2 symptoms during the surveillance period will be enrolled in the project. Among those tested, a questionnaire will be used to confirm that the employee is eligible for participation. These clinical illness criteria below were developed in consultation with CDC to align with FDA criteria for vaccine clinical trials, but they are subject to revision during project startup activities.
CRITERIA 1. At least ONE of the following respiratory signs/symptoms:
• Shortness of breath or difficulty breathing;
• Cough; or
• Severe respiratory illness with either clinical or radiographical evidence of pneumonia or acute respiratory distress syndrome (ARDS).
OR
CRITERIA 2. At least TWO of the following signs/symptoms:
• Fever (within episode of illness);
• Myalgia;
• New olfactory and taste disorder(s);
• Chills;
• Rigors;
• Headache; or
• Sore throat.
Any person who participated in a COVID-19-related vaccine trial may be included, but detailed information about enrollment and allocation will be required.
Eligible employees can be enrolled more than once (if the employee tested negative during a prior enrollment), but after being enrolled they will be ineligible for a period of 4 weeks after the time of enrollment, and they must have had complete resolution of symptoms from the time of the first episode of testing.

Exclusion CriteriaAny employee who was previously diagnosed with laboratory confirmed COVID-19 infection (RT-PCR, or antigen) will be ineligible (including previous project participants who tested positive during prior participation). Any person unable to confirm test results or vaccine administration using an approved method will also be excluded. Any previously enrolled HCP who did not complete the follow-up survey during a previous enrollment will be ineligible for re-enrollment.

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Rebekah Peacock
Phone Number: 601-815-3008
Email: rpeacock@umc.edu
Principal Investigator:Nandi, Utsav, M.D.
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