NCT04603677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

October 25, 2020

Last Update Submit

March 19, 2023

Conditions

Covid19

Keywords

biobankbiorepositorySARS-CoV-2 infectionCOVID-19coronavirus

Outcome Measures

Primary Outcomes (1)

  • Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease

    Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease

    6 months

Secondary Outcomes (1)

  • Evaluation of markers and predictors of post acute sequelae of COVID-19

    2 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • under 18 years of age
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Poudre Valley Hospital, UCHealth

Fort Collins, Colorado, 80523, United States

Location

Greeley Hospital, UCHealth

Greeley, Colorado, 80634, United States

Location

Medical Center of the Rockies, UCHealth

Loveland, Colorado, 80538, United States

Location

Related Publications (3)

  • Whitcomb LA, Berry K, LaVergne SM, Natter N, Baxter BA, Rao S, Tipton M, Gritsenko MA, Weitz KK, Gerbasi V, Bramer LM, Piehowski PD, Webb TL, Henao-Tamayo M, Chicco AJ, Dunn J, Dutt TS, Ryan EP. Blood pro-thrombotic analytes and platelet activation are associated with post-acute sequelae of COVID-19. BMC Infect Dis. 2025 Dec 10. doi: 10.1186/s12879-025-11824-3. Online ahead of print.

    PMID: 41372813DERIVED

  • Stromberg S, Baxter BA, Dooley G, LaVergne SM, Gallichotte E, Dutt T, Tipton M, Berry K, Haberman J, Natter N, Webb TL, McFann K, Henao-Tamayo M, Ebel G, Rao S, Dunn J, Ryan EP. Relationships between plasma fatty acids in adults with mild, moderate, or severe COVID-19 and the development of post-acute sequelae. Front Nutr. 2022 Sep 14;9:960409. doi: 10.3389/fnut.2022.960409. eCollection 2022.

    PMID: 36185653DERIVED

  • LaVergne SM, Stromberg S, Baxter BA, Webb TL, Dutt TS, Berry K, Tipton M, Haberman J, Massey BR, McFann K, Alnachoukati O, Zier L, Heacock T, Ebel GD, Henao-Tamayo M, Dunn J, Ryan EP. A longitudinal SARS-CoV-2 biorepository for COVID-19 survivors with and without post-acute sequelae. BMC Infect Dis. 2021 Jul 13;21(1):677. doi: 10.1186/s12879-021-06359-2.

    PMID: 34256735DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, stool, saliva, nasopharyngeal swab specimens

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bridget Baxter

    Colorado State University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 27, 2020

Study Start

July 8, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

US(4)