Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid

• Conditions: COVID-19

• Registration Number: NCT05618600
• Lead Sponsor: Scripps Translational Science Institute

Brief Summary

A prospective monitoring study for those individuals treated with Paxlovid

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 Timeline

• Study Start: 2022-08-04
• Status Verified: 2022-11
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16
• Primary Completion: 2023-07
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Age > 18
• Covid positive
• Qualified for Paxlovid prescription (treatment decision already made prior to enrollment)

Exclusion Criteria

• Non-english speaking
• Resides outside of the United States

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Scripps Research Institute; 🇺🇸 San Diego, California, United States