Northern Colorado COVID-19 Biobank (NoCo-CoBio)

March 19, 2023 updated by: Elizabeth P Ryan, Colorado State University

Northern Colorado Coronavirus Biobank: A Biorepository for Acute and Convalescent Patient Samples From Coloradoans Infected With SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2)

The NoCo-CoBio Project is a biobanking effort to store and preserve saliva, nasopharyngeal, stool and blood specimens from SARS-CoV-2 PCR (polymerase chain reaction) positive individuals.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators have created a biorepository of stool, saliva, nasopharyngeal swab specimens, peripheral blood mononuclear cells, serum, and plasma from SARS-CoV-2 infected individuals for research purposes. The multifaceted biorepository will be used to establish markers predicting various presentations of COVID-19 (coronavirus disease 2019).

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

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

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University
      • Fort Collins, Colorado, United States, 80523
        • Poudre Valley Hospital, UCHealth
      • Greeley, Colorado, United States, 80634
        • Greeley Hospital, UCHealth
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies, UCHealth

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

The investigators aim to enroll individuals who have had a positive SARS-CoV-2 PCR, with a goal of enrolling 100 hospitalized patients with acute SARS-CoV-2 infection, as well as 100 convalescent participants.

Description

Inclusion Criteria:

  • Those who have had a positive SARS-CoV-2 PCR test

Exclusion Criteria:

  • under 18 years of age
  • pregnant

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

Cohorts and Interventions

Group / Cohort
Acute phase of SARS-CoV-2 infection
Participants with an acute SARS-CoV-2 infection. Intervention will not be implemented in this study.
Convalescent phase of SARS-CoV-2 infection
Participants with a previous diagnosis of SARS-CoV-2 infection, now in the convalescent phase of disease. Intervention will not be implemented in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease
Time Frame: 6 months
Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of markers and predictors of post acute sequelae of COVID-19
Time Frame: 2 years
Evaluation of markers and predictors of post acute sequelae of COVID-19
2 years

Collaborators and Investigators

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

Sponsor

Colorado State University

Collaborators

University of Colorado Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 8, 2020

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

October 25, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-10063H

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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