SARS-CoV-2 InfectionCOVID-19NCT04815018

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

An observational study of SARS-CoV-2 Infection and Bacterial Respiratory Tract Infection, run by Pathnostics at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, Bacterial Respiratory Tract Infection, Viral Respiratory Tract Infection
How many people: 185 participants
Where: 4 sitesUnited States
Study dates: 7 Oct 2020to 30 May 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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 locations and contacts

4 sites in 1 country.

United States4 sites

Willow Brook Christian Village
Delaware, Ohio, 43015
Willow Brook Delaware Run
Delaware, Ohio, 43015
Kendall at Granville
Granville, Ohio, 43023
Inniswood Village
Westerville, Ohio, 43081

Other trials in United States

About this study

Official title: A Longitudinal Observational Study Identifying Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2 in Nursing Home Residents

Read the 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.

Conditions: SARS-CoV-2 Infection, Bacterial Respiratory Tract Infection, Viral Respiratory Tract Infection
Keywords: Nursing Home, COVID-19, Respiratory Microbiome
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04815018
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to any timepoint for 4 to 8 weeks

Secondary outcomes (4)

ALPHA Diversity (determined by NGS)
Defined as intra-community diversity as measured by the total number of detected taxa and distribution of those taxa.
Measured: 6-12 months
Taxon Identification (determined by NGS)
Defined as intra-community diversity as measured by the total number of detected taxa and distribution of those taxa.
Measured: 6-12 months
BETA Diversity (determined by NGS)
Defined as inter-community diversity as measured by the total number of detected taxa and distribution of those taxa.
Measured: 6-12 months
Frequency of Detection (Determined by NGS)
Frequency of detection of the total amount of bacterial DNA/RNA that corresponds to specific bacterial taxa found within nasal swab/ exhaled breath
Measured: 6-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202030 May 2021

First posted24 Mar 2021
Study start7 Oct 2020
Primary completion30 May 2021
Study completion30 May 2021

Why it stopped: Failure to Accrue

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04815018
Sponsor's protocol ID: 2020-rmcovid
Acronym: COVID-19
Status last verified: Jun 2021
First submitted: 11 Mar 2021
Last updated: 30 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Longitudinal Observational Study Identifying Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2 in Nursing Home Residents
ClinicalTrials.gov ID: NCT04815018
Acronym / sponsor ID: COVID-19 / 2020-rmcovid
Conditions: SARS-CoV-2 Infection, Bacterial Respiratory Tract Infection, Viral Respiratory Tract Infection
Keywords: Nursing Home, COVID-19, Respiratory Microbiome
Study type: Observational
Recruitment status: TerminatedReason stopped: Failure to Accrue
Enrolment: 185 participants (actual)
Lead sponsor: PathnosticsIndustry (pharma, biotech, devices)
Study start: 7 Oct 2020 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 30 May 2021 (actual)
First posted: 24 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percent of SARS-CoV-2 infection
Time frame: 4-8 weeks
Examine prospective data to determine the change from baseline (week 1 of testing) in resident/bed ratio positive for SARS-CoV-2.
Percent of SARS-CoV-2 and bacterial co-infection
Time frame: 4-8 weeks
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.
Percent of SARS-CoV-2 and viral co-infection
Time frame: 4-8 weeks
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.
Mortality rate due to SARS-CoV-2 infection with bacterial/viral co-infection
Time frame: 12 months
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.
Mortality rate due to SARS-CoV-2 infection
Time frame: 12 months
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.
Symptoms of SARS-CoV-2 infection, bacterial co-infection, viral co-infection
Time frame: Up to 12 weeks post-PCR confirmation for a SARS-CoV-2 positive diagnosis
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.
Percent of SARS-Cov-2 positives and/or bacterial/viral infection with full resolution by 30 days
Time frame: Up to 30 days after respiratory symptom onset
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].
Percent of SARS-Cov-2 positives and/or bacterial/viral infection that develop pneumonia-like symptoms
Time frame: 4-8 weeks
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
Percent of asymptomatic SARS-Cov-2 positives and/or bacterial/viral infection
Time frame: 4-8 weeks
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.
Percent of pre-symptomatic SARS-Cov-2 positives and/or bacterial/viral infection
Time frame: 4-8 weeks
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.
Percent of all acute medical complications
Time frame: 4-8 weeks
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
Pulmonary function
Time frame: Baseline to any timepoint for 4 to 8 weeks
Examine prospective data to determine the the percent change in forced vital capacity (FVC), forced expiratory volume (FEV1), peak expiratory flow (PEF) in patients
Chest CT X-ray
Time frame: Baseline to any timepoint for 4 to 8 weeks
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
Changes in hematology
Time frame: Baseline to any timepoint for 4 to 8 weeks
Examine prospective data to identify changes in patient hematology through analysis of complete blood routines for CBC and WBC.

4 secondary outcomes

ALPHA Diversity (determined by NGS)
Time frame: 6-12 months
Taxon Identification (determined by NGS)
Time frame: 6-12 months
BETA Diversity (determined by NGS)
Time frame: 6-12 months
Frequency of Detection (Determined by NGS)
Time frame: 6-12 months

Results and safety

The study was stopped early (reason given: Failure to Accrue). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alan Wolfe, MD principal investigator

Loyola University Chicago

Kirk Wojno, MD principal investigator

Comprehensive Urology

John Weigand, MD principal investigator

Central Ohio Geriatrics

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 Infection and Bacterial Respiratory Tract Infection, run by Pathnostics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Failure to Accrue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of SARS-CoV-2 infection (time frame: 4-8 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.