Clinical trial NCT04603677: Northern Colorado COVID-19 Biobank
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: biobank
biorepository
SARS-CoV-2 infection
COVID-19
coronavirus
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: University of Colorado Health
First posted: 2020-10-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* under 18 years of age
* pregnant

Primary outcomes:
measure: Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of markers and predictors of post acute sequelae of COVID-19
timeFrame: 2 years
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital, UCHealth
state: Colorado
city: Greeley
country: United States
facility: Greeley Hospital, UCHealth
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies, UCHealth
state: Colorado
Study officials:
affiliation: Colorado State University
name: Bridget Baxter
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.