A Study to Assess the Culture, PCR, Serology and Symptoms of COVID-19
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-004544
About this study
The purpose of this study is to understand when patients are shedding active COVID virus RNA as detectable by viral culture, and if there are any correlates of the cessation of active viral shedding, such as presence of certain immunoglobulins.
Additionally, this study will take a discovery approach to the immune response to better understand how the body recovers or worsens during disease, and if there are opportunities to use that knowledge to develop treatments.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Topic 1 - Series collection for Inpatients
Inclusion Criteria - Topic 1:
- Hospitalized patients with positive PCR result for SARS-CoV-2. Patients may also be consented for any treatment trial.
- Patients may decide to participate in both this and the enterprise-wide biobanking study (IRB 20-003014). In this case, the collections for Biobanking would take precedence, and the interval in which the Biobanking is collected would take the place of a collection for this study. For example, if Biobank collects a sample for Day 7, then this study would not have a sample for Day 7-9.
- Patients who are discharged from the hospital could continue to be followed under Topic 2
- Note: patients may continue to participate even if they choose to skip a collection point or skip a specimen type. Specimen collection may also be skipped at any time point if collection is not feasible.
Exclusion Criteria - Topic 1:
- Refusal to consent for any additional testing.
Topic 2 - Prospective, serial collection for Outpatients
Inclusion Criteria:
- Outpatients with positive PCR result for SARS-CoV-2.
- Patients may also be consented for any treatment trial.
- Patients may decide to participate in both this and another study.
- Note: patients may continue to participate even if they choose to skip a collection point or skip a specimen type. Specimen collection may also be skipped at any time point if collection is not feasible.
Exclusion Criteria:
- Refusal to consent for any additional testing.
Topic 3 - Viral culture/Sequencing of unique specimens
Inclusion Criteria:
Exclusion Criteria:
Topic 4 - Evaluation of plate-based and lateral flow serologic assays
Inclusion Criteria:
- For the plate-based assays: Clinical residuals would be used with consent waiver for anyone coming for standard of care blood tests.
- For the LFIA: Outpatients with known PCR result for SARS-CoV-2 (whether positive or negative), or, outpatients who have received a vaccination for SARS-CoV-2. All adult patients arriving to the drive-through testing area (phlebotomy or swab collection) or phlebotomy areas would also be eligible for the study. Patients may be called by study coordinators based on known positive or negative PCR results. Patients may also be consented for any treatment trial. Patients may decide to participate in both this and another study.
Exclusion Criteria:
- (LFIA) Anyone who does not want to receive a fingerprick or collect saliva or nasal swab.
Topic 5 - Antigenic evaluation of serologic responses
Inclusion Criteria:
Exclusion Criteria:
Topic 6 - Isolation of human peripheral blood mononuclear cells (PBMC) for development of human monoclonal antibodies, and investigation of HLA types and T cell epitopes
Topic 7 - SARS-CoV-2 and microbiome sequencing
Inclusion Criteria:
Exclusion Criteria:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Thomas Grys, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available