Oral Microbiome, COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
This is an observational study, cohort prospective, 2 parallel arms [Cohort A: subject SARS-Cov-2 positive
Cohort B: subjects SARS-Cov-2 negative] involving an estimated minimum number of 20 participants. Every subject will be sampled at least once
it would be possible a maximum of 3 samples for the subjects assigned to Cohort A.
The data will be stratified according to cohort, age, gender, infection time. Admission into the stud
enrolment
baseline data recording, included anamnestic clinical condition at recruitment time and the result of the molecular diagnostic test for detecting SARS-Cov-2
Cohort assignment (Cohort A: molecular diagnosis for SARS-Cov-2 infection POSITIVE, valid also for patients already hospitalized in wards specifically identified by Azienda Ospedaleria Universitaria o
Cohort B: molecular diagnosis for SARS-Cov-2 infection NEGATIVE.
Visit 1 – Baseline sampling (Cohort A and Cohort B, mandatory), oral microbiome sampling with a non-invasive procedure
Visit 3 – Late sampling (Cohort A, optional), oral microbiome sampling with a non-invasive procedure (oral rinse – after 14 days from molecular diagnosis and at least 7
Sponsors
University of Ferrara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 18 years old; 2. Received a reliable molecular diagnosis response for SARS-Cov-2 infection (positive/negative) 3. Availability for the study duration (6 months) 4. Possibility to give consent to study participation (for written or verbal option)
Exclusion criteria
Exclusion criteria: 1. Current radiotherapy or chemotherapy 2. Unreliable molecular diagnosis response for SARS-Cov-2 infection 3. Impossibility to give consent to study participation (for written or verbal option)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of the microbial communities colonizing the oral cavity in patients infected by SARS-Cov-2 at visit 1 (baseline), 2 (0 - 14 days from diagnosis), 3 (at least 7 days after end of treatment). Methods include two types of molecular analyses for RNA and DNA: 1) Whole Genome Sequencing (WGS); 2) quantitative real-time PCR microarray. | — |
Secondary
| Measure | Time frame |
|---|---|
| At visit 1 (baseline), 2 (0 - 14 days from diagnosis), 3 (at least 7 days after end of treatment): 1. Presence and concentration of IgA and IgG anti-SARS-Cov-2 in the oral rinse of the participant positive to the virus will also be evaluated (CE ELISA test) 2. Concentration of pro-inflammatory cytokines (Multy-Analyte ELISArray test) | — |
Countries
Italy
Outcome results
None listed