Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2

NCT04815018 | Terminated

• 1 other identifier: 2020-rmcovid
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Nursing Home; COVID-19; Respiratory Microbiome

Outcome Measures

Primary Outcomes (14)

• Percent of SARS-CoV-2 infection

  Examine prospective data to determine the change from baseline (week 1 of testing) in resident/bed ratio positive for SARS-CoV-2.

  4-8 weeks

• Percent of SARS-CoV-2 and bacterial co-infection

  Examine prospective data to determine the change from baseline number of healthy \[SARS-CoV-2 naïve\] to number that develop respiratory tract infection. Percent of SARS-CoV-2 positives without a bacterial source of RTI compared to percent of SARS-CoV-2 positives with bacterial co-infection identified by either PCR, symptoms, CXR, CT, throat culture swab, RDT and documented in patient chart.

  4-8 weeks

• Percent of SARS-CoV-2 and viral co-infection

  Examine prospective data to determine the change from baseline number of healthy \[SARS-CoV-2 naïve\] to number that develop respiratory tract infection. Percent of SARS-CoV-2 positives without an additional viral cause identified compared to percent of SARS-CoV-2 positives with viral co-infection identified.

  4-8 weeks

• Mortality rate due to SARS-CoV-2 infection with bacterial/viral co-infection

  Examine prospective data to determine the mortality rate (outpatient and inpatient) due to SARS-CoV-2 with additional bacteria and/or virus identified at any time during SARS-Cov-2 PCR positivity prior to death.

  12 months

• Mortality rate due to SARS-CoV-2 infection

  Examine prospective data to determine the mortality rate (outpatient and inpatient) due to SARS-CoV-2 only (no additional bacteria and/or virus identified on PCR at any time during SARS-CoV-2 PCR positivity prior to death.

  12 months

• Symptoms of SARS-CoV-2 infection, bacterial co-infection, viral co-infection

  Any changes in symptom severity will be captured by monitoring the patient's chart for any updates in clinical progress notes. Any symptoms compatible with SARS-CoV-2 infection will be captured such as high temperature, dyspnea, diarrhea, vomiting, myalgia, pharynx pain, abdominal pain, anosmia, cough etc.

  Up to 12 weeks post-PCR confirmation for a SARS-CoV-2 positive diagnosis

• Percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days

  Examine prospective data to determine the percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days after respiratory symptom onset \[full resolution defined as resolution of acute onset clinical symptoms\].

  Up to 30 days after respiratory symptom onset

• Percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms

  Examine prospective data to determine the percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms during SARS-CoV-2 PCR positivity

  4-8 weeks

• Percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection

  Examine prospective data to determine the percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection that never develop symptoms throughout infectious period and are alive/healthy at end of study.

  4-8 weeks

• Percent of pre-symptomatic SARS-Cov-2 positives and/or bacterial/viral infection

  Examine prospective data to determine the percent of pre-symptomatic SARS-CoV-2 positives and/or bacterial/viral infection. This is the asymptomatic period PRIOR to a symptomatic period all during time of PCR positivity.

  4-8 weeks

• Percent of all acute medical complications

  Examine prospective data to determine the prevalence of all medical usual complications and geriatric acquired complications, such as delirium, falls, pressure sores, new infectious disease (UTI), cardiovascular, incidence of acute heart failure \[elevated BNP presence of new ECG abnormalities (ST elevation and/or T-wave inversion), myocardial injury \[reflected by elevation in cardiac troponin levels above the 99th percentile upper reference limit on admission, cerebrovascular disease \[Stroke, stroke subtype (ischemic, cryptogenic , metabolic disease manifestations DKA, hyperosmolar hyperglycemic state (HHS), and severe insulin resistance, Neurological Manifestations \[Anosmia/dysgeusia, Guillen Barre Syndrome, Meningoencephalitis, Encephalomyelitis, myoclonus (generalized), Rhabdomyolysis, VTE, DIC, PE, acute limb ischemia

  4-8 weeks

• Pulmonary function

  Examine prospective data to determine the the percent change in forced vital capacity (FVC), forced expiratory volume (FEV1), peak expiratory flow (PEF) in patients

  Baseline to any timepoint for 4 to 8 weeks

• Chest CT X-ray

  Examine prospective data to determine the percent of lung CT containing consolidation, percent of patients showing reticular patterns, percent containing pure ground-glass opacification, percent containing honeycomb appearance, percent containing Bronchiectasis

  Baseline to any timepoint for 4 to 8 weeks

• Changes in hematology

  Examine prospective data to identify changes in patient hematology through analysis of complete blood routines for CBC and WBC.

  Baseline to any timepoint for 4 to 8 weeks

Secondary Outcomes (4)

• ALPHA Diversity (determined by NGS)

  6-12 months

• Taxon Identification (determined by NGS)

  6-12 months

• BETA Diversity (determined by NGS)

  6-12 months

• Frequency of Detection (Determined by NGS)

  6-12 months

Study Arms (2)

Patients with New Cases of SARS-CoV-2

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

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pathnostics: lead

Study Sites (4)

Willow Brook Christian Village

Delaware, Ohio, 43015, United States

Location

Willow Brook Delaware Run

Delaware, Ohio, 43015, United States

Location

Kendall at Granville

Granville, Ohio, 43023, United States

Location

Inniswood Village

Westerville, Ohio, 43081, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alan Wolfe, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

• Kirk Wojno, MD

  Comprehensive Urology

  PRINCIPAL INVESTIGATOR

• John Weigand, MD

  Central Ohio Geriatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 24, 2021
• Study Start: October 7, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)