Study protocol

TASK 31 Protocol development M1M3 Julius Clinical Ava UMCU Roche Within this task the protocol for the cohort study will be developed The study will be a prospective observational study in a set of three clearlydefined cohorts that follows the course of the disease exposure development of disease symptoms and disease outcomes during the initial and following waves of the COVID epidemic in order to answer the research questions introduced above Cohort recruitment will be staggered over multiple waves through the course of the study The three cohorts will be recruited contemporaneously within each wave The study will have the following characteristicsSize and composition of the three cohortsDevice plus signs and symptoms diary 20koCohort 1 13k sample from general populationoCohort 2 7k highrisk sample highrisk individuals due to agecomorbidities or profession Signs and symptoms diary comparator 20koCohort 3 20k sampled from general and highrisk population Study populationlocation The Netherlands current users of an existing PROssymptoms app created by the OLVG hospital in AmsterdamAdults 18 years and over with enrichment for highrisk personsOutcome measuresCollection of SARSCoV2 infection status negative or positive via PCR for participants who are referred or for participants who otherwise obtain such resultsConfirmation of SARSCoV2 status via serology for all participants at the end of followupHealthcare utilisation incl treatments usedClinical prognosis at the time of diagnosed SARSCoV2 and survival statusTime to testVariablesDiary collection of signs and symptoms on a routine basisNighttime average skin temperature heart rate and breathing rate Cohorts 1 and 2 collected each day of study participationBaseline demographics and comorbiditiesBaseline medicationsBaseline finger prick samples to enable full or partial assessment of SARSCoV2 status via serologyChanges in comorbidities andor medicationsDuration of use for device users Participants will be followed for an initial period of at least 34 months with an option to extend participation A staggered enrolment approach will be used to ensure continuous observation over the course of the duration of the study Recruitment for the three cohorts will take place via OLVG andor Luscii who will contact the current users of the Corona Check App on behalf of COVIDRED No userlevel data will be needed by COVIDRED to subselect the research participants who will be contacted In case this recruitment procedure does not deliver as per protocol and study plan a social media campaign will be set up More details on the procedures and criteria that will be used to identifyrecruit research participants will be provided prior to the start of the research activity as part of the study protocol D31 Since COVIGAPP is already underway as a separate study there are no COVIGAPP recruitment or identification elements that are supported within COVIDRED This project will include participants at higher risk of COVID19 infection due to health or demographic status or due to their employment We do not consider the device to directly impact their risks Theoretically the device could indirectly impact COVID19 risks or outcomes based on changes in participant behaviours This will be addressed in the informed consent training materials video and participants will be in direct contact with triage support in those cases where there is a suspicion of COVID19 infection This is the same triage team which assesses Dutch nationals today and recommends GP or hospital followup Patient privacy is an important feature of this study and health data will not be accessible to the public Identifiable data will be collected with consent and limited to those systems where necessary Where not necessary only a uniqueuser ID will be use