Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2 (COVID-19)

Pathnostics

Status: Terminated

Conditions: SARS-CoV-2 Infection; Viral Respiratory Tract Infection; Bacterial Respiratory Tract Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT04815018

2020-rmcovid

Details and patient eligibility

About

This is a longitudinal, prospective observational study focusing on health-related outcomes relative to potential changes in the respiratory microbiome seen with weekly SARS-CoV-2 testing in nursing home residents.

Full description

This study targets the influence of SARS-CoV-2, and the presence of mixed/co-infections on the respiratory microbiome. Their interrelationship will be characterized in a prospective observational study design. The observed changes will be correlated to medical (FEV1, CXR/CT, mortality, morbidity, symptoms) and clinical laboratory parameters (hematology, coagulation, bacterial/viral detection). The study aims at the detection of significant changes in microbiome in the respiratory tract following incidence of SARS-CoV-2 infection. These alterations in the respiratory microbiome will be determined by shotgun metagenomic sequencing. Ultimately, this can provide a better understanding of how SARS-CoV-2 and the presence of other bacteria and viruses affect the composition of the respiratory microbiome and a description of the microbiological etiology of these respiratory tract infections.

Enrollment: 185 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All residents of the nursing home facility, (M/F) 65 years or above, who have recently tested positive through Ohio's PARRT Program are eligible
• Resident must submit weekly nasal swab sample per nursing home COVID testing guidelines
• Clinical suspicion of a new episode of acute respiratory tract infection.
• Laboratory confirmed SARS-CoV-2 infection by either a laboratory test, PCR or any other commercial or public health test

Exclusion criteria

• Nursing home residents that are not taking part regularly in weekly screening for SARS-COV-2 or residents that test negative through Ohio's PARRT program cannot be included as part of study analyses
• Residents on hospice, residents currently intubated, residents with scheduled transfer to another nursing home facility will not be included in study analyses

Trial design

185 participants in 2 patient groups

Patients with New Cases of SARS-CoV-2

Description:

Newly recruited residents who have been identified as positive through Ohio's Post-Acute Regional Rapid Testing (PARRT) Program will undergo at at least 4 weeks, but no more than 8 weeks, of nasal swab and exhaled breathe particles specimen collection for Covid testing. Previously enrolled residents will submit weekly collections of nasal swab specimens and exhaled breathe particles once they exhibit respiratory-related symptoms, or once a test is ordered by the provider for suspicion of exposure. Collection will continue until these subjects fulfill their 8 weeks of testing.

Patients without SARS-CoV-2

Description:

This cohort will consist of previously enrolled residents who submitted nasal swabs and exhaled breathe particles for Covid testing once a week for 8 weeks. The patients will have been identified as negative for a SARS-CoV-2 infection each week.