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NCT04331886 Clinical Trial

An Observational Study of Patients With Coronavirus Disease 2019

COVID-19 Clinical Trial

— COVID-19  

Official title:
An Observational Study of Patients With Coronavirus Disease 2019

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04331886
Other study ID # TARGET-COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 13, 2020
Est. completion date March 2024

Study information
Verified date January 2022
Source Target PharmaSolutions, Inc.
Contact Chuck Moser
Phone 984-234-0268
Email cmoser@targetpharmasolutions.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Target PharmaSolutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Natural history of COVID-19: Characteristics of COVID-19 12 months
Primary Natural history of COVID-19: Participant demographics 12 months
Primary Natural history of COVID-19: Treatment use 12 months
Primary Time point of clinical response 12 months
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