RecruitingACTRN12626000290392

OUTComes POST Viral Infection: The OUTPOST study

OUTComes POST Viral Infection (OUTPOST): A prospective cohort study of Post Viral Syndrome prevalence in Australians over the age of 12


Sponsor

The University of Melbourne

Enrollment

2,000 participants

Start Date

Aug 17, 2024

Study Type

Observational

Conditions

Summary

The primary aim of the study is to define the point-prevalence of a Post-Viral Syndrome (PVS, Long COVID) at 12-24 weeks post SARS Cov-2 infection versus infective (RSV A/B or Influenza A/B) and non-infective controls using an operationalised PVS research case definition in the Australian community. The study will also help to understand: - how often SARS-CoV-2 infection and other respitatory viral infections cause PVS , - what symptoms (and symptom clusters) occur, and - what medical, mental health and functional impact those symptoms may have. We will screen-swab up to 10,000 participants aged 12+ with recent onset (<7 days) respiratory symptoms, to enroll a total of 500 confirmed acute SARS-CoV-2 infection cases, 500 Influenza cases and 500 RSV cases, as well as 500 non-infective control subjects across Australia. Participants will be tested for respiratory viruses including SARS-CoV-2, Influenza A/B, RSV A/B. Up to a total of 2000 participants who are positive for SARS CoV-2, Influenza A/B, RSV A/B and non-infective controls will be followed up at 6, 12, 24 and 48 weeks via self-reported questionnaires to assess for ongoing symptoms and application of a standardised PVS case definition. The OUTPOST cohort will provide a basis for health economic analysis. The cohort will complement a concurrent mapping exercise of existing studies and cohorts on Long COVID in addition to specialist support services and clinics around the country. Together, these project activities will inform better care and support for people experiencing Long COVID in Australia.


Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

Long COVID — persistent symptoms lasting weeks or months after a COVID-19 infection — has affected millions of people worldwide. But it's not yet clear how often long COVID occurs compared to long-lasting symptoms after other respiratory infections like flu or RSV, nor what the defining features are. This large Australian study, called OUTPOST, aims to answer these questions rigorously. Researchers will screen up to 10,000 people who develop respiratory symptoms. Those confirmed to have COVID-19, influenza, RSV, or no infection at all will be followed up with questionnaires at 6, 12, 24, and 48 weeks to track any ongoing symptoms. The study will produce clear data on how often post-viral syndromes occur, what symptoms they involve, and what impact they have on daily life. You may be eligible if you are 12 years or older and have had recent respiratory symptoms (within 7 days). People who already have Long COVID, previous COVID-19 in the last 3 months, a diagnosis of chronic fatigue syndrome, fibromyalgia, or POTS, or pre-existing significant fatigue, breathlessness, cognitive difficulties, or sleep disturbance are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The OUTPOST study is investigating the symptoms of confirmed SARS-CoV-2, RSV or Influenza infection over a 48 week period. Participants initially self-administer a Rapid Antigen Test and enrol if posi

The OUTPOST study is investigating the symptoms of confirmed SARS-CoV-2, RSV or Influenza infection over a 48 week period. Participants initially self-administer a Rapid Antigen Test and enrol if positive for one of three respiratory viruses. Online questionnaires are completed at baseline (with repeat questionnaires referring to both the period before illness and the current period of acute illness), and then at weeks 6, 12, 24 and 48. The questionnaires include: Somatic and Psychological HEalth REport physical symptoms and fatigue subscale (SPHERE SOMA, fatigue), Modified Medical Research Council Dyspnoea scale (mMRC, dyspnoea), Patient’s Assessment of Own Functioning (PAOFI, cognition), Pittsburgh Sleep Quality Index (PSQI, sleep disturbance), the World Health Organization Disability Assessment Schedule-12 (WHODAS-12), Kessler Psychological Distress Scale-10 (Kessler-10, mood), McGill short form (pain), Composite Autonomic Symptom Score-31 (COMPASS-31, autonomic disturbance), Multidimensional Scale of Perceived Social Support (MSPPSS, social support), Healthcare Utilisation Questionnaire and Work Productivity and Activity Impairment Questionnaire (WPAIQ, work). Questionnaires at each timepoint take 20-30 minutes to complete.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12626000290392


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