TITLE: vBio Voice Analysis
AUTHORS: David Levesque

[STEPS]
?. [Demographic & Endpoints]
Study ProtocolAges Eligible for Study: 18 Years and older  (Adult, Older Adult) Sexes Eligible for Study: Male FemaleAll Accepts Healthy Volunteers: YesNo Sampling Method: Non-Probability SampleSites: 60 hospitals, Africa, EU, Asia, U.S.Study PopulationsPatients with positive COVID-19 PCR test results within 14 days.Healthy volunteersOutcome measuresAccuracy of positive and negative test results generated by the vocal analysis software compared to PCR.Primary endpoints (collected within 14 days of positive PCR results)Two 30 second voice recordingsCOVID-19 test resultsSecondary Endpoints (optional)IGG, IGM, other factors found via the voice analysis softwareIGG, IGM levels post recovery (this is optional as it requires a second engagement with the patient, which we may do if we have appropriate funding)MedicationsComorbidities/conditionsAgeGenderZip Code or other location informationPatient experience score on a scale of 1-5 (See potential instruments here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4511995/
?. [Inclusion & Exclusion Criteria]
Inclusion Criteria:Male or female, aged > 18 yearsProvide a valid electronic informed consent formStated willingness to provide evidence of their lab test resultsPregnant or lactating women may participateExclusion Criteria:Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgeryPrior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cordsTreatment with another investigational drug or device within 30 days prior to signing ConsentExclusion Criteria:Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgeryPrior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cordsTreatment with another investigational drug or device within 30 days prior to signing Consent
?. [Inclusion & Exclusion Criteria]
Proposed Study processPartners for patients receives ethic board approval at the hospitalThe hospital approves Partners for patients to contact their doctors about the studyPartners for patients speaks with doctors to educate them on the study protocolDoctor or Research coordinator talks with patients about their interest in participating    a)  Doctors could give us consent to talk to the patientDoctors/ research coordinator emails the consent to patients    a) Patient signs the PDF consent form and emails it back to the doctor    b) Doctor emails the patient the link to the GoNoGo study interface            1.  We could add the consent form to the study interfaceThe patient records their voice sampleThe patient enters their name and email addressThe audio file and name and email address is sent to GoNoGoThe file is analyzedThe patient’s test results are retrieved from the Clinerion database and added to the GoNoGo data to confirm diagnosisPatients are invited to participate in an online support communityUpon study completion, lay person study summaries are delivered to patients via email or an app