Clinical Trials

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:

• None.

Exclusion Criteria:

• Consent waived.

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:

• None.

Exclusion Criteria:

• Consent waived.

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:

• None.

Exclusion Criteria:

• Consent waived.