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

November 14, 2022 updated by: Jay Pandit, Scripps Translational Science Institute
A prospective monitoring study for those individuals treated with Paxlovid

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92126
        • Scripps Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paxlovid Rebound
Time Frame: 16 day period
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

eMed

Investigators

  • Principal Investigator: Jay Pandit, MD, Scripps Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScrippsTSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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