NCT04815018

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Pathnostics · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Timeline

• Start date: 2020-10-07
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2021-03-24
• Last updated: 2021-06-30

Locations

4 sites across 1 country: United States