TY - JOUR
T1 - The COVID HOME study research protocol
T2 - Prospective cohort study of non-hospitalised COVID-19 patients
AU - Tami, Adriana
AU - van der Gun, Bernardina T.F.
AU - Wold, Karin I.
AU - Vincenti-González, María F.
AU - Veloo, Alida C.M.
AU - Knoester, Marjolein
AU - Harmsma, Valerie P.R.
AU - de Boer, Gerolf C.
AU - Huckriede, Anke L.W.
AU - Pantano, Daniele
AU - Gard, Lilli
AU - Rodenhuis-Zybert, Izabela A.
AU - Upasani, Vinit
AU - Smit, Jolanda
AU - Dijkstra, Akkelies E.
AU - de Haan, Jacco J.
AU - van Elst, Jip M.
AU - van den Boogaard, Jossy
AU - O’ Boyle, Shennae
AU - Nacul, Luis
AU - Niesters, Hubert G.M.
AU - Friedrich, Alex W.
N1 - Funding Information:
The project received funding from the Netherlands Organisation for Health Research and Development (ZonMw)[23], grant 10430012010023, and as partner of the ORCHESTRA project [24] which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101016167. The views expressed in this publication are the sole responsibility of the author and the Commission is not responsible for any use that may be made of the information it contains. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We would like to firstly thank all the participants of the COVID HOME study for their ongoing contribution to the project and to the understanding of COVID-19. Our thanks also go to the Clinical Virology (Molecular and Serology) unit and to the Infection Prevention section, in special to Jet van der Weerd (Head of Infection Prevention), all part of the Department of Medical Microbiology & Infection Prevention, UMCG; as well as Lars van Heerden (manager) and the staff from the Laboratory of General Haematology and Chemistry, Laboratory Medicine, UMCG; to Myke Mol and Paul Koenes from the Service Desk Clinical Research Office, UMCG, the Netherlands; and to Cesar Cuadra, microbiologist, for invaluable support during writing of the study protocol. Lastly, we would like to thank the collaboration of the Municipal Public Health Services (GGD) of Groningen and Drenthe with the recruitment of study participants in this region.
Publisher Copyright:
© 2022 Tami et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
U2 - 10.1371/journal.pone.0273599
DO - 10.1371/journal.pone.0273599
M3 - Article
C2 - 36327223
AN - SCOPUS:85141889855
SN - 1932-6203
VL - 17
JO - PLoS ONE
JF - PLoS ONE
IS - 11
M1 - e0273599
ER -