Covid19NoCo-CoBioNCT04603677
Northern Colorado COVID-19 Biobank
An observational study of Covid19, run by Colorado State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 148 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jul 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Those who have had a positive SARS-CoV-2 PCR test
Who cannot join
- under 18 years of age
- pregnant
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Colorado State University
Fort Collins, Colorado, 80523
Poudre Valley Hospital, UCHealth
Fort Collins, Colorado, 80523
Greeley Hospital, UCHealth
Greeley, Colorado, 80634
Medical Center of the Rockies, UCHealth
Loveland, Colorado, 80538
About this study
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)
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.
Read the 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).
- Conditions
- Covid19
- Keywords
- biobank, biorepository, SARS-CoV-2 infection, COVID-19, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Evaluation of markers and predictors of post acute sequelae of COVID-19
Evaluation of markers and predictors of post acute sequelae of COVID-19
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start8 Jul 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado Health
- Responsible party
- Principal investigator, Elizabeth P Ryan, Colorado State University
- Investigators
- Bridget Baxter, Study director, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603677
- Sponsor's protocol ID
- 20-10063H
- Acronym
- NoCo-CoBio
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2020
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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;26(1):61. doi: 10.1186/s12879-025-11824-3.
PubMed 41372813Stromberg 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.
PubMed 36185653LaVergne 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.
PubMed 34256735
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04603677
- Acronym / sponsor ID
- NoCo-CoBio / 20-10063H
- Conditions
- Covid19
- Keywords
- biobank, biorepository, SARS-CoV-2 infection, COVID-19, coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado Health
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Those who have had a positive SARS-CoV-2 PCR test
Key exclusion criteria (2 listed)
- under 18 years of age
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Evaluation of markers and predictors of post acute sequelae of COVID-19
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 41372813Whitcomb 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;26(1):61. doi: 10.1186/s12879-025-11824-3.
- Derived from this study: PubMed 36185653Stromberg 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.
- Derived from this study: PubMed 34256735LaVergne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget Baxter study director
Colorado State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Colorado State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of parameters for markers of SARS-CoV-2 infection and predictors for severe disease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603677, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.