Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
Study Details
Study Description
Brief Summary
A prospective monitoring study for those individuals treated with Paxlovid
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The purpose of this study is to understand the epidemiology and pathophysiology of Paxlovid rebound in patients with acute Covid-19 infection who have been prescribed the Paxlovid per standard of care.
The study will be a collaborative effort between Scripps and eMed, digitally recruiting 800 participants who have tested positive for Covid-19 and have agreed to be prescribed Paxlovid on the eMed platform.
The vision of the study is to understand Paxlovid rebound and ultimately inform management of acute Covid-19 infection.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
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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. |
Outcome Measures
Primary Outcome Measures
- Paxlovid Rebound [16 day period]
Incidence of paxlovid rebound defined as test positivity after a documented negative rapid antigen test post 5 day course of Paxlovid
Other Outcome Measures
- Symptomatology long term [6 month period]
Understand the long term impact of paxlovid rebound on symptomatology
- Number of viral rebound [16 day period]
Differences in viral rebound between control and paxlovid group
- Number of grouped symptomatology [16 day period]
Differences in symptomatology between control and paxlovid group.
- Immune profile [6 month period]
Differences in immune profile between control and paxlovid group
- Viral Evolution [6 month period]
Differences in viral evolution between control and paxlovid group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18
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Covid positive
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Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)
Exclusion Criteria:
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Non-english speaking
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Resides outside of the United States
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Scripps Research Institute | San Diego | California | United States | 92126 |
Sponsors and Collaborators
- Scripps Translational Science Institute
- eMed
Investigators
- Principal Investigator: Jay Pandit, MD, Scripps Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ScrippsTSI