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

Active, not recruiting

• Conditions: COVID-19 Vaccines

• Registration Number: NCT04832932
• Lead Sponsor: Mebo Research, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-05
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-06
• Primary Completion: 2023-01-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Study Completion: 2025-01-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse reactions/events	10 days after any dose of study intervention.	Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2

Secondary Outcome Measures

Name	Time	Method
Long-term adverse events	Throughout the study period, until 12 months post-final-dose	Percentage of occurrence, types, duration and severity of adverse events throughout study period
Incidence of COVID-19 cases	From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose	The number of COVID-19 cases occurring \<=14 or ≥ 15 days after any dose of study intervention.

Trial Locations

Locations (5)

MEBO Research, Inc; 🇺🇸 Miami, Florida, United States

Kahite; 🇺🇸 Vonore, Tennessee, United States

Gabashvili; 🇬🇪 Tbilisi, Georgia

MEBO Research Africa; 🇰🇪 Kilifi, Kenya

Mebo Research (Uk); 🇬🇧 London, England, United Kingdom