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

COVID-19 Clinical Trial

— COVID-HOME  

Official title:

Prospective Cohort Study of Non-hospitalised COVID-19 Patients: Determining Length of Isolation and Patient Clinical Development at Home (COVID-HOME Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06282627
• Other study ID #: 10430012010023
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

Other:
• Observational study
No intervention. Observational study

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection	SARS-CoV-2 positive individuals by qRT-PCR	Three weeks of acute follow-up
Secondary	Long-term sequelae	Reporting at least one symptom at 3, 6, 12 months post-infection	2 years

External Links

•   Study protocol