COVID-19 Clinical Trial
— COVID-HOMEOfficial title:
Prospective Cohort Study of Non-hospitalised COVID-19 Patients: Determining Length of Isolation and Patient Clinical Development at Home (COVID-HOME Study)
Verified date | February 2024 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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
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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