Clinical trial NCT06282627: The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients
Official title: Prospective Cohort Study of Non-hospitalised COVID-19 Patients: Determining Length of Isolation and Patient Clinical Development at Home (COVID-HOME Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Post-COVID-19 Syndrome
Keywords: COVID-19
SARS-CoV-2
Non-hospitalised
Post-COVID-19 Syndrome
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-02-28
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is carried out amongst residents of the Northern Provinces of the Netherlands (Groningen, Friesland, Overijssel and Drenthe) comprising around 1.7 million inhabitants. Laboratory confirmed SARS-CoV-2 infected individuals of all ages (index cases) that do not merit hospitalisation, and their HH members, were invited to join the study and enrolled after signing a written informed consent. Consenting parents/guardians of infected children (≤16 years) signed the informed consent form. The complete HH, i.e. all persons (contacts) living in the same home, was to join the study at enrolment. If this requirement was not fulfilled, the HH was excluded from the study.

Brief summary: Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.

The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.

Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) 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 and 21 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-months post-infection to assess long-term sequelae and immunological status.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 infection
timeFrame: Three weeks of acute follow-up
Secondary outcomes:
measure: Long-term sequelae
timeFrame: 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen, University of Groningen, Groningen, The Netherlads
name: Adriana TAMI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tami A, van der Gun BTF, Wold KI, Vincenti-Gonzalez MF, Veloo ACM, Knoester M, Harmsma VPR, de Boer GC, Huckriede ALW, Pantano D, Gard L, Rodenhuis-Zybert IA, Upasani V, Smit J, Dijkstra AE, de Haan JJ, van Elst JM, van den Boogaard J, O' Boyle S, Nacul L, Niesters HGM, Friedrich AW. The COVID HOME study research protocol: Prospective cohort study of non-hospitalised COVID-19 patients. PLoS One. 2022 Nov 3;17(11):e0273599. doi: 10.1371/journal.pone.0273599. eCollection 2022.