Background. Guidelines on COVID-19 management are developed as we learn from thispandemic. However, most research has been done on hospitalised patients and the impact ofthe disease on non-hospitalised and their role in transmission are not yet wellunderstood.The COVID HOME study conducts research among COVID-19 patients and their family memberswho were not hospitalised during acute disease, to guide patient care and inform publichealth guidelines for infection prevention and control in the community and household.Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatientswas established in March 2020 at the beginning of the COVID-19 pandemic in theNetherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that didnot merit hospitalisation, and their household (HH) members, were enrolled after writteninformed consent. Enrolled participants were visited at home within 48 hours afterinitial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a bloodsample for biochemical parameters/cytokines and serological determination; and anasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (ifconsenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing.Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and21 were also taken from HH members to determine whether and when they became infected.All participants were invited to continue follow-up at 3-, 6-, 12- and 18-monthspost-infection to assess long-term sequelae and immunological status.
An ongoing prospective longitudinal observational study of SARS-CoV-2 infected
individuals that did not require hospitalisation and their HH members was initiated on
March 2020, at the start of the pandemic in the Netherlands.
Enrolled individuals comprised the identified laboratory COVID-19 index positive patients
plus all their HH members. The average number of HH inhabitants in the Netherlands and
the northern region is 2.14 [44], thus for each enrolled patient we expected to enrol an
average of 1-2 HH members in addition. Patients were followed daily at home approximately
during 3 weeks post-infection to characterize their acute clinical phenotype, and are
currently being followed at 3, 6, 12 and 18 months to determine their long-term clinical
and serological evolution. During the follow-up, clinical data and different types of
samples were/are collected, as described below.
Other: Observational study
No intervention. Observational study
Inclusion Criteria:
- Onset of symptoms <5 days before inclusion
- Positive diagnostic RT-PCR for SARS-CoV-2 performed within 48h of inclusion
- Index person should supply all required samples in the protocol for the duration of
the study
- All HH members should join the study
- Signing of informed consent form
Exclusion Criteria:
- False positive RT-PCR test
- Non compliance with study follow-up
University Medical Center Groningen
Groningen 2755251, Netherlands
Adriana TAMI, Principal Investigator
University Medical Center Groningen, University of Groningen, Groningen, The Netherlads