Clinical trial NCT04815018: Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2
Official title: A Longitudinal Observational Study Identifying Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2 in Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SARS-CoV-2 Infection
Bacterial Respiratory Tract Infection
Viral Respiratory Tract Infection
Keywords: Nursing Home
COVID-19
Respiratory Microbiome
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 185
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly recruited patients are older adults (≥ 65 years) and pre-geriatric (≥60 years and \<65 years) residents of nursing homes who have recently been identified as SARS-CoV-2 positive through Ohio's PARRT Program.

Subjects currently enrolled are older adults (≥ 65 years) and pre-geriatric (≥60 years and \<65 years) residents of nursing homes

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of SARS-CoV-2 infection
timeFrame: 4-8 weeks
measure: Percent of SARS-CoV-2 and bacterial co-infection
timeFrame: 4-8 weeks
measure: Percent of SARS-CoV-2 and viral co-infection
timeFrame: 4-8 weeks
measure: Mortality rate due to SARS-CoV-2 infection with bacterial/viral co-infection
timeFrame: 12 months
measure: Mortality rate due to SARS-CoV-2 infection
timeFrame: 12 months
measure: Symptoms of SARS-CoV-2 infection, bacterial co-infection, viral co-infection
timeFrame: Up to 12 weeks post-PCR confirmation for a SARS-CoV-2 positive diagnosis
measure: Percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days
timeFrame: Up to 30 days after respiratory symptom onset
measure: Percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms
timeFrame: 4-8 weeks
measure: Percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection
timeFrame: 4-8 weeks
measure: Percent of pre-symptomatic SARS-Cov-2 positives and/or bacterial/viral infection
timeFrame: 4-8 weeks
measure: Percent of all acute medical complications
timeFrame: 4-8 weeks
measure: Pulmonary function
timeFrame: Baseline to any timepoint for 4 to 8 weeks
measure: Chest CT X-ray
timeFrame: Baseline to any timepoint for 4 to 8 weeks
measure: Changes in hematology
timeFrame: Baseline to any timepoint for 4 to 8 weeks
Secondary outcomes:
measure: ALPHA Diversity (determined by NGS)
timeFrame: 6-12 months
measure: Taxon Identification (determined by NGS)
timeFrame: 6-12 months
measure: BETA Diversity (determined by NGS)
timeFrame: 6-12 months
measure: Frequency of Detection (Determined by NGS)
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Delaware
country: United States
facility: Willow Brook Christian Village
state: Ohio
city: Delaware
country: United States
facility: Willow Brook Delaware Run
state: Ohio
city: Granville
country: United States
facility: Kendall at Granville
state: Ohio
city: Westerville
country: United States
facility: Inniswood Village
state: Ohio
Study officials:
affiliation: Loyola University Chicago
name: Alan Wolfe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Urology
name: Kirk Wojno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Ohio Geriatrics
name: John Weigand, MD
role: PRINCIPAL_INVESTIGATOR
References: