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

NCT ID: NCT05618600

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-04

Study Completion Date

2024-01-31

Brief Summary

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A prospective monitoring study for those individuals treated with Paxlovid

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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eMed

UNKNOWN

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Jay Pandit

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay Pandit, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Research Institute

Locations

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Scripps Research Institute

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ScrippsTSI

Identifier Type: -

Identifier Source: org_study_id

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