Fever Tracking Study

NCT ID: NCT05475067

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-07

Study Completion Date

2022-03-05

Brief Summary

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The aim of this study is to investigate the feasibility of continuous fever tracking of participants having fever symptoms in a home setting, using a core body temperature (CBT) sensor. CBT as measured by the wearable sensors will be coampared with CBT as measured by ingestible electronc pills (reference).

A secondary research question is, if the CBT behavior of the the participants in a home setting can be compared to previously described CBT profiles in the literature, and if special patterns can be identified.

Detailed Description

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Conditions

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Core Body Temperature in Healthy Subjects Immune Response to mRNA COVID-19 Vaccination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 18-60 years old
* Informed consent signed
* Either:

Acute fever symptoms at inclusion (at least 38.0°C) and Test for COVID-19 at the day of inclusion

\- Or: Second shot or booster of mRNA COVD-19 vaccination (Comirnaty® or COVID-19 Vaccine Moderna®) at day of inclusion

Exclusion Criteria

* Any participant who, for any reason, is unable to independently consent to participate in the study and/or who is unable to independently follow the study protocol.
* Any participant with previous surgical procedures in the gastrointestinal tract
* Inability to swallow pills
* Any participant of ≤40 kg body weight
* A scheduled MRI examination in the period from the start of the measurements until seven days after ingestion of the electronic pill.
* Any participant being pregnant
* Impairment or disability of the upper extremity likely to have a negative impact on the quality of measurements:

* Wounds
* Active venous access
* Amputations
* Dialysis shunt
* Edema
* Axillary dissection
* Continuous long-term monitoring of blood pressure
* Tattoos
* Known allergy to plastics / latex
* Language problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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greenTEG AG

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Eckstein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Universitiy Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Fever Tracking

Identifier Type: -

Identifier Source: org_study_id

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