The COVID HOME study research protocol: Prospective cohort study of non-hospitalised COVID-19 patients

Abstract

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.

Fig 1. Acute and long-term follow-up timeline of participants enrolled in the COVID HOME study.

Fig 2. Sampling flowchart for positive and negative SARS-CoV-2 participants.

NPT= nasopharyngeal/throat.

Fig 3. Case report forms (CRF) applied to study participants.

CRF-01 and CRF-03 are applied to all participants while CRF-10a is answered by non-infected individuals. All other CRFs are applied to SARS-CoV-2 infected individuals.