A pilot study to determine whether respiratory-responsice vocal biomarkers (RRVB) either alone or in combination with symptom inventory can identify Covid-19 patients versus asymptomatic healthy controls. - SH2020.COV01

Sonde Health0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1 Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app (access to smartphone provided by parent or legal guardian of participants under the age 18 is allowed)
•2 Willing to sign up for a Sonde app account
•3 Agreement with the subject consent information presented on the Sonde app. In case of adolescent subjects, agreement with subject consent information provided by a parent or legal guardian
•4 Stated willingness and ability to comply with all study procedures for the duration of the study
•5 Male or female, aged 12 or above (including adults)
•6 Able to read and speak English or Marathi (required to follow app instructions and provide correct voice elicitations)
•7 Pregnant women are allowed to participate
•Only for subjects in subgroups 1a and 1b (suspected COVID-19 patients):
•8 Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1
•9 Suspected COVID-19 includes patients having at least one of the following symptoms that are present at most 10 days prior to enrollment:
•Fever ( >37.5 oC/ 99.5 oF)
•Shortness of breath
•Sore throat
•Loss of taste/ ageusia
•10 COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1
•Only for subjects in subgroup 2:
•11 Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study
•12 Age 12 and above

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Difficulties with speech production
•2. Difficulties reading or responding to instructions and questions on a smartphone screen
•3. Critical COVID-19 illness severity at screening on Day 1
•4. Other critical health condition where study participation would place unreasonable burden or risk on the patient as determined by the study site principal investigator
•For subjects in subgroup 2:
•5. History of positive COVID-19 viral or serologic test result any time prior to enrollment
•6. Any hospital staff that is a member of the study team, and staff in the pulmonary and infectious disease departments of the participating institution, or any of their co-living family members

发起方

Sonde Health