The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients

NCT06282627 | Completed DMC

• 1 other identifier: 10430012010023
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Post-COVID-19 Syndrome

Keywords

COVID-19; SARS-CoV-2; Non-hospitalised; Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

  SARS-CoV-2 positive individuals by qRT-PCR

  Three weeks of acute follow-up

Secondary Outcomes (1)

• Long-term sequelae

  2 years

Study Arms (1)

Non-hospitalised individuals

No intervention. Observational study

Other: Observational study

Interventions

Observational study OTHER

No intervention. Observational study

Non-hospitalised individuals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• False positive RT-PCR test
• Non compliance with study follow-up

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36327223 RESULT

Related Links

• Study protocol

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Adriana TAMI

  University Medical Center Groningen, University of Groningen, Groningen, The Netherlads

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: February 28, 2024
• Study Start: March 20, 2020
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

NL (1)