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 range60 Years

SexALL

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

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

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

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 range60 Years

SexALL

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

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