A Study to Assess the Culture, PCR, Serology and Symptoms of COVID-19

Overview

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: Serial collection of inpatient samples with culture, PCR, and serology

Inclusion Criteria:

  • Hospitalized patients with positive PCR result for SARS-CoV-2.
  • 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 before Day 21 would continue to be followed, but would move to a weekly sample collection schedule as in 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:

  • Refusal to consent for any additional testing. 

Topic 2: Serial collection of outpatient samples with culture, PCR, and serology

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: Culture investigations of unique clinical specimens

  • Patients with positive PCR result for SARS-CoV-2.

Topic 4: Clinical evaluation of rapid serology test

Inclusion Criteria:

  • Outpatients with positive PCR result for SARS-CoV-2 who are returning for follow-up care. All adult patients arriving to the drive-through testing area (phlebotomy or swab collection) would also be eligible for the study. Patients may also be consented for any treatment trial.  Patients may decide to participate in both this and another study.

Exclusion Criteria:

  • Anyone who does not want to receive a fingerprick.

Topic 5: Antigenic evaluation of serologic responses:

  • Patients with positive PCR result for SARS-CoV-2.

Topic 6: Isolation of PBMCs for derivation of human monoclonal antibodies, HLA typing, and for measuring T cell immunity

  • Patients consenting for participation in related study through ASU.

Topic 7: SARS-CoV-2 and microbiome sequencing

  • Patients with postive PCR result for SARS-CoV-2.

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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Thomas Grys, Ph.D.

Open for enrollment

Contact information:

Thomas Grys Ph.D.

(480) 342-1615

Grys.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available