None listed
Conditions
Brief 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.
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 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.
Sponsors
Eligibility
Inclusion criteria
Enrolled within 7 days of onset of acute respiratory infection symptoms or, for non-infective controls, registered for study and enrolled following a negative Rapid Antigen Test for SARS-CoV-2, RSV and Flu.
Exclusion criteria
For both infective and non-infective control subjects, a history, or current diagnosis of, Long COVID; persistent symptoms from previous COVID-19 infection; a COVID-19 infection in the last 3 months; current diagnosis of recognised chronic illness potentially linked to infection including chronic fatigue syndrome (CFS) / fibromyalgia (FM) / postural orthostatic tachycardia syndrome (POTS); a pre-existing chronic symptom of the core features of Long COVID, including any of: clinically significant fatigue, dyspnoea, cognitive dysfunction or sleep disturbance