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COVID-19: An Observational Study of Patients With Coronavirus Disease 2019

Sponsor
Target PharmaSolutions, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04331886
Collaborator
(none)
5,000
Enrollment
1
Location
46.6
Anticipated Duration (Months)
107.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    An Observational Study of Patients With Coronavirus Disease 2019
    Actual Study Start Date :
    Apr 13, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Natural history of COVID-19: Characteristics of COVID-19 [12 months]

    2. Natural history of COVID-19: Participant demographics [12 months]

    3. Natural history of COVID-19: Treatment use [12 months]

    4. Time point of clinical response [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection.

    • SARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction [PCR] or other clinically utilized test).

    Exclusion Criteria:

    N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • Target PharmaSolutions, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Target PharmaSolutions, Inc.
    ClinicalTrials.gov Identifier:
    NCT04331886
    Other Study ID Numbers:
    • TARGET-COVID-19
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronavirus Infections
    COVID-19

    Study Results

    No Results Posted as of Jan 18, 2022