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NCT05618600 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05618600
Other study ID # ScrippsTSI
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 4, 2022
Est. completion date January 2024

Study information
Verified date November 2022
Source Scripps Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective monitoring study for those individuals treated with Paxlovid

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 800
Est. completion date January 2024
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Scripps Research Institute San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Scripps Translational Science Institute eMed

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Symptomatology long term Understand the long term impact of paxlovid rebound on symptomatology 6 month period
Other Number of viral rebound Differences in viral rebound between control and paxlovid group 16 day period
Other Number of grouped symptomatology Differences in symptomatology between control and paxlovid group. 16 day period
Other Immune profile Differences in immune profile between control and paxlovid group 6 month period
Other Viral Evolution Differences in viral evolution between control and paxlovid group 6 month period
Primary 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
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