The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes

Mebo Research

Status: Active, not recruiting

Conditions: COVID-19 Vaccines

Treatments: Biological: COVID-19 vaccines

Study type: Observational

Funder types: Other

Identifiers

NCT04832932

20210103MEBO

Details and patient eligibility

About

During the study, members of different online and offline communities will be followed post COVID-19 vaccination.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference.

Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

Full description

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals 18 or older at the time of consent
• Intention to vaccinate and of being available for entire study period

Exclusion criteria

• Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Trial design

2,000 participants in 6 patient groups

80 years of age or older

Description:

Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines

60-79 years of age

Description:

Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines

40-59 years of age

Description:

Individuals in 40-49, 50-59 age range who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines

18-39 years of age

Description:

Individuals in 18-29, 30-39 age range who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines

MEBO/PATM

Description:

Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines

Chronic Disease

Description:

Individuals with self-reported chronic health conditions who received COVID-19 vaccine

Treatment:

Biological: COVID-19 vaccines