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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331886
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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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
COVID-19 Coronavirus

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Natural history of COVID-19: Characteristics of COVID-19 [ Time Frame: 12 months ]
  2. Natural history of COVID-19: Participant demographics [ Time Frame: 12 months ]
  3. Natural history of COVID-19: Treatment use [ Time Frame: 12 months ]
  4. Time point of clinical response [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331886


Contacts
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Contact: Chuck Moser 984-234-0268 cmoser@targetpharmasolutions.com

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT04331886    
Other Study ID Numbers: TARGET-COVID-19
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
COVID-19
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
 Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases