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

January 14, 2022 updated by: Target PharmaSolutions, Inc.
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data for up to 5,000 hospitalized patients with a positive diagnosis of coronavirus disease 2019 (COVID-19) in the United States will be collected in TARGET-COVID-19.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Natural history of COVID-19: Characteristics of COVID-19
Time Frame: 12 months
12 months
Natural history of COVID-19: Participant demographics
Time Frame: 12 months
12 months
Natural history of COVID-19: Treatment use
Time Frame: 12 months
12 months
Time point of clinical response
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Target PharmaSolutions, Inc.

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)

April 13, 2020

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-COVID-19

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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