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Northern Colorado COVID-19 Biobank (NoCo-CoBio)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603677
Recruitment Status : Active, not recruiting
First Posted : October 27, 2020
Last Update Posted : February 22, 2022
Sponsor:
Collaborator:
University of Colorado Health
Information provided by (Responsible Party):
Elizabeth P Ryan, Colorado State University

Brief Summary:
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.

Condition or disease
Covid19

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).

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Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
blood, stool, saliva, nasopharyngeal swab specimens


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
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • under 18 years of age
  • pregnant

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): NCT04603677


Locations
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United States, Colorado
Colorado State University
Fort Collins, Colorado, United States, 80523
Poudre Valley Hospital, UCHealth
Fort Collins, Colorado, United States, 80523
Greeley Hospital, UCHealth
Greeley, Colorado, United States, 80634
Medical Center of the Rockies, UCHealth
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
Colorado State University
University of Colorado Health
Investigators
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Study Director: Bridget Baxter Colorado State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth P Ryan, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT04603677    
Other Study ID Numbers: 20-10063H
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth P Ryan, Colorado State University:
biobank
biorepository
SARS-CoV-2 infection
COVID-19
coronavirus
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases