TerminatedNot Applicable

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

Stopped: Failure to Accrue

United States185 participantsStarted 2020-10-07

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of SARS-CoV-2 infection

Timeframe: 4-8 weeks

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

Timeframe: 4-8 weeks

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

Timeframe: 4-8 weeks

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

Timeframe: 12 months

Mortality rate due to SARS-CoV-2 infection

Timeframe: 12 months

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

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

Trial details

NCT IDNCT04815018

SponsorPathnostics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05-30

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent of SARS-CoV-2 infection

Timeframe: 4-8 weeks

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

Timeframe: 4-8 weeks

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

Timeframe: 4-8 weeks

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

Timeframe: 12 months

Mortality rate due to SARS-CoV-2 infection

Timeframe: 12 months

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

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