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Completed

NCT Number: NCT05618600

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

A prospective monitoring study for those individuals treated with Paxlovid

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Research Institute

San Diego, California, 92126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Other outcomes

  1. Symptomatology long term

    Time frame: 6 month period

    Understand the long term impact of paxlovid rebound on symptomatology

  2. Number of viral rebound

    Time frame: 16 day period

    Differences in viral rebound between control and paxlovid group

  3. Number of grouped symptomatology

    Time frame: 16 day period

    Differences in symptomatology between control and paxlovid group.

  4. Immune profile

    Time frame: 6 month period

    Differences in immune profile between control and paxlovid group

  5. Viral Evolution

    Time frame: 6 month period

    Differences in viral evolution between control and paxlovid group

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • eMed

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 16, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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