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COVID-19 Research Response (ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections COVID-19 Research Response Trial)

ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections COVID-19 Research Response Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000444987
Acronym
CRR
Enrollment
100000
Registered
2020-04-06
Start date
2020-04-07
Completion date
Unknown
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

- This clinical trial aims at describing the clinical features of COVID-19, the response to treatment, as well as pathogen replication, excretion and evolution within the host, determinants of severity and transmission using high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood and stool. - Characterise the host responses to infection and therapy over time, including innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood - Identify host genetic variants associated with disease progression or severity - Understand transmissibility and probabilities of different clinical outcomes following exposure and infection

Interventions

Exposure to COVID-19. Participant involvement is required, including but not limited to extra nasopharyngeal swabs, blood draws, as well as possible surveys (local site intervention is bound to ISARIC protocol). There may be follow-up after discharge, at 3 and 6 month timepoints (protocol is evolving).

Sponsors

South Metropolitan Health Service
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Suspected or proven novel Coronavirus (nCoV) infection as main reason for admission or presentation to hospital or clinic.

Exclusion criteria

Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen Refusal by participant, parent, or appropriate representative. Any other reason, as determined by the Lead Investigator or treating clinician, that the patient should not be included in the study, in-line with ICH GCP (E6 R2) requirements and the Australian Code for Responsible Conduct of Research (2018).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026