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

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05618600
Collaborator
eMed (Other)
800
1
16.9
47.3

Study Details

Study Description

Brief Summary

A prospective monitoring study for those individuals treated with Paxlovid

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Scripps-eMed Covid-19 Study: A Prospective Monitoring Study for Those Individuals Treated With Paxlovid
    Actual Study Start Date :
    Aug 4, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Symptomatology long term [6 month period]

      Understand the long term impact of paxlovid rebound on symptomatology

    2. Number of viral rebound [16 day period]

      Differences in viral rebound between control and paxlovid group

    3. Number of grouped symptomatology [16 day period]

      Differences in symptomatology between control and paxlovid group.

    4. Immune profile [6 month period]

      Differences in immune profile between control and paxlovid group

    5. Viral Evolution [6 month period]

      Differences in viral evolution between control and paxlovid group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Jay Pandit, Study Principal Investigator, Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT05618600
    Other Study ID Numbers:
    • ScrippsTSI
    First Posted:
    Nov 16, 2022
    Last Update Posted:
    Nov 16, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jay Pandit, Study Principal Investigator, Scripps Translational Science Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2022