NCT04579588RecruitingNot Applicable
Understanding Immunity to the Flu Vaccine in COVID-19 Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Testing immunity to the flu vaccine over time
Study Overview
Brief Summary
The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 9 Years to 64 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 9 through 64 years
- •Diagnosed with COVID-19 at least 2 months prior enrollment
- •Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
- •Patients without COVID-19 diagnosis for controls
Exclusion Criteria
- •Received the influenza vaccine less than 4 months ago
- •Pregnant or lactating
- •Patients with special risks attendant to venipuncture
- •Use of immunomodulatory medications that may impact vaccine immune response per clinician's judgment
- •Contraindication to the flu vaccine
- •Immunodeficiency or autoimmune disease that may impact vaccine immune responses per clinician's judgement
Arms & Interventions
COVID-19 participants
Intervention: Flu shot (Biological)
Control participants
Intervention: Flu shot (Biological)
Outcomes
Primary Outcomes
Testing immunity to the flu vaccine over time
Time Frame: 1 month
Testing immunity to the flu vaccine over time
Time Frame: 1 week
Secondary Outcomes
No secondary outcomes reported
Investigators
Sayantani B. Sindher
Associate Professor of Medicine
Stanford University
Study Sites (1)
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