Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
1 other identifier
observational
917
1 country
1
Brief Summary
A prospective monitoring study for those individuals treated with Paxlovid
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2022
CompletedFirst Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedApril 24, 2026
April 1, 2024
1.3 years
November 11, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Paxlovid Rebound
Incidence of paxlovid rebound defined as test positivity after a documented negative rapid antigen test post 5 day course of Paxlovid
16 day period
Other Outcomes (5)
Symptomatology long term
6 month period
Number of viral rebound
16 day period
Number of grouped symptomatology
16 day period
- +2 more other outcomes
Study Arms (2)
Paxlovid Cohort
Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 1 will include 400 participants that opt to take the 5-day course of Paxlovid. Participation will look identical in this study.
Control Cohort
Participants will be separated into 2 arms that are self-selected through the decision to opt in or out of Paxlovid. After patients are offered a 5-day course of Paxlovid and have made a treatment decision they will be eligible to join the study. Arm 2, control, will include 400 participants that opt out of taking the 5-day course of Paxlovid. Participation will look identical in this study.
Eligibility Criteria
The study population will be obtained from the eMed platform and will consist of participants that tested positive using an eMed rapid antigen test, who underwent a telemedicine visit and opted in or out of receiving a prescription for a 5-day course of Paxlovid.
You may qualify if:
- Age \> 18
- Covid positive
- Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)
You may not qualify if:
- Non-english speaking
- Resides outside of the United States
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Translational Science Institutelead
- eMedcollaborator
Study Sites (1)
Scripps Research Institute
San Diego, California, 92126, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Pandit, MD
Scripps Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
November 11, 2022
First Posted
November 16, 2022
Study Start
August 4, 2022
Primary Completion
December 8, 2023
Study Completion
June 10, 2024
Last Updated
April 24, 2026
Record last verified: 2024-04