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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06282627
Other study ID # 10430012010023
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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